Systems and Methods for Treating Septal Defects

ABSTRACT

A system for treating a septal defect having an implantable treatment apparatus and devices for delivering the implantable treatment apparatus and methods for treating a septal defect are provided. The implantable treatment apparatus is preferably implantable through a septal wall or portion thereof. The treatment system can include a flexible elongate body member, a delivery device configured to deliver the implantable apparatus, a stabilization device configured to stabilize the body member and a positioning device configured to position the delivery device in a desired location.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.11/175,814, filed Jul. 5, 2005, which is a continuation-in-part of U.S.patent application Ser. No. 10/847,747, filed on May 7, 2004, which is acontinuation-in-part of U.S. patent application Ser. No. 10/734,670,filed Dec. 11, 2003, which is a division of Ser. No. 09/948,453, filedSep. 7, 2001, now U.S. Pat. No. 6,702,835 and which is acontinuation-in-part of Ser. No. 09/948,502, filed Sep. 6, 2001, nowU.S. Pat. No. 6,776,784, which is fully incorporated herein byreference.

FIELD OF THE INVENTION

The present invention relates generally to systems and methods forclosing internal tissue defects, and more particularly to systems andmethods for closing a patent foramen ovale or other septal defect.

BACKGROUND OF THE INVENTION

By nature of their location, the treatment of internal tissue defects isinherently difficult. Access to a defect through invasive surgeryintroduces a high level of risk that can result in serious complicationsfor the patient. Access to the defect remotely with a catheter orequivalent device is less risky, but treatment of the defect itself ismade more difficult given the limited physical abilities of thecatheter. The difficulty in accessing and treating tissue defects iscompounded when the defect is found in or near a vital organ. Forinstance, a patent foramen ovale (“PFO”) is a serious septal defect thatcan occur between the left and right atria of the heart and a patentductus arteriosus (“PDA”) is an abnormal shunt between the aorta andpulmonary artery.

During development of a fetus in utero, oxygen is transferred frommaternal blood to fetal blood through complex interactions between thedeveloping fetal vasculature and the mother's placenta. During thisprocess, blood is oxygenated within the fetal lungs. In fact, most ofthe fetus' circulation is shunted away from the lungs throughspecialized vessels and foramens that are open during fetal life, buttypically will close shortly after birth. Occasionally, however, theseforamen fail to close and create hemodynamic problems, which, in extremecases, can ultimately prove fatal. During fetal life, an opening calledthe foramen ovale allows blood to pass directly from the right atrium tothe left atrium (bypassing the lungs). Thus, blood that is oxygenatedvia gas exchange with the placenta may travel through the vena cava intothe right atrium, through the foramen ovale into the left atrium, andfrom there into the left ventricle for delivery to the fetal systemiccirculation. After birth, with pulmonary circulation established, theincreased left atrial blood flow and pressure causes the functionalclosure of the foramen ovale and, as the heart continues to develop,this closure allows the foramen ovale to grow completely sealed.

In some cases, however, the foramen ovale fails to close entirely. Thiscondition, known as a PFO, can allow blood to continue to shunt betweenthe left and right atria of the heart throughout the adult life of theindividual. A PFO can pose serious health risks for the individual,including strokes and migraines. The presence of PFO's have beenimplicated as a possible contributing factor in the pathogenesis ofmigraine. Two current hypothesis that link PFO's with migraine includethe transit of vasoactive substances or thrombus/emboli from the venouscirculation directly into the left atrium without passing through thelungs where they would normally be deactivated or filtered respectively.Other diseases that have been associated with PFO's (and which couldbenefit from PFO closure) include but are not limited to depression andaffective disorders, personality and anxiety disorders, pain, stroke,TIA, dementia, epilepsy, and sleep disorders.

Still other septal defects can occur between the various chambers of theheart, such as atrial-septal defects (ASD's), ventricular-septal defects(VSD's), and the like. To treat these defects as well as PFO's, openheart surgery can be performed to ligate and close the defect.Alternatively, catheter-based procedures have been developed thatrequire introducing umbrella or disc-like devices into the heart. Thesedevices include opposing expandable structures connected by a hub orwaist. Generally, in an attempt to close the defect, the device isinserted through the natural opening of the defect and the expandablestructures are deployed on either side of the septum to secure thetissue surrounding the defect between the umbrella or disc-likestructure.

These devices suffer from numerous shortcomings. For instance, thesedevices typically involve frame structures that often support membranes,either of which may fail during the life of the patient, therebyintroducing the risk that the defect may reopen or that portions of thedevice could be released within the patient's heart. These devices canfail to form a perfect seal of the septal defect, allowing blood tocontinue to shunt through the defect. Also, the size and expansivenature of these devices makes safe withdrawal from the patient difficultin instances where withdrawal becomes necessary. The presence of thesedevices within the heart typically requires the patient to useanti-coagulant drugs for prolonged periods of time, thereby introducingadditional health risks to the patient. Furthermore, these devices cancome into contact with other portions of the heart tissue and causeundesirable side effects such as an arrhythmia, local tissue damage, andperforation.

Accordingly, improved systems and methods for closing internal tissuedefects within the heart are needed.

SUMMARY

Improved systems and methods for closing internal tissue defects, suchas septal defects and the like, are provided herein by the way ofexemplary embodiments. These embodiments are examples only and are notintended to limit the invention.

In one exemplary embodiment, an implantable apparatus for treating aseptal defect is provided having a body with a first end portion, asecond end portion and a central portion located therebetween.Preferably, the first end portion is configured to engage a first septalsurface, the second end portion is configured to engage a second septalsurface and the central portion is configured to fit within an openingin a septal wall.

In another exemplary embodiment, a treatment system is provided having afirst elongate member and a second elongate delivery member having adistal end rotatably coupled with the first elongate member, wherein theorientation of the distal end is adjustable from a first orientation toa second orientation upon advancement of the elongate member in a distaldirection.

In another exemplary embodiment, a treatment system is provided havingan implantable treatment device, a flexible elongate delivery devicehaving a first longitudinal axis and configured to deliver theimplantable treatment device, and an elongate body member having asecond longitudinal axis and configured for insertion within thevasculature of a patient, the body member configured to slidably receivethe delivery device, where the delivery device is configured to deliverthe implantable treatment device along the first longitudinal axis whendifferent than the second longitudinal axis.

In another exemplary embodiment, a treatment system is provided havingan elongate tubular member having an inner lumen configured to slidablyreceive and interact with an inner elongate member. Preferably, theinner elongate member is configured to deploy a grasping device throughan aperture in the elongate tubular member upon movement of the elongateinner member with respect to the elongate tubular member.

In yet another exemplary embodiment, a treatment system is providedhaving a flexible positioning member having a distal end and an elongatesupport member having an inner lumen configured to slidably receive theflexible positioning member. Preferably, the inner lumen has a distalend configured to abut the distal end of the flexible positioning memberand an open portion located proximal to the distal end of the lumen. Theflexible positioning member is also preferably configured to extend fromthe open portion upon advancement of the flexible positioning memberdistally against the distal end of the inner lumen.

another exemplary embodiment, a method of treating a septal defect isprovided, the method including abutting a limbus of a septum secundumwith an abutment of a medical device, creating a hole in the septumsecundum with the limbus as a point of reference, and using the hole tofacilitate delivery of a device configured to treat a septal defect.

In another exemplary embodiment, a treatment system is provided havingan implantable treatment device, a flexible elongate delivery deviceconfigured to deliver the implantable treatment device, a stabilizationdevice insertable within an opening in a septum, or tunnel between twosepta, and configured to stabilize an elongate body member, and theelongate body member configured for insertion within the vasculature ofa patient, the body member configured to slidably receive the deliverydevice and stabilization device.

Other systems, methods, features and advantages of the invention will beor will become apparent to one with skill in the art upon examination ofthe following figures and detailed description. It is intended that allsuch additional systems, methods, features and advantages be includedwithin this description, be within the scope of the invention, and beprotected by the accompanying claims. It is also intended that theinvention is not limited to require the details of the exampleembodiments.

BRIEF DESCRIPTION OF THE FIGURES

The details of the invention, both as to its structure and operation,may be gleaned in part by study of the accompanying figures, in whichlike reference numerals refer to like parts. The components in thefigures are not necessarily to scale, emphasis instead being placed uponillustrating the principles of the invention. Moreover, allillustrations are intended to convey concepts, where relative sizes,shapes and other detailed attributes may be illustrated schematicallyrather than literally or precisely.

FIG. 1 is a block diagram depicting an exemplary embodiment of atreatment system.

FIG. 2A is an exterior/interior view of the right atrium depicting anexample human heart.

FIGS. 2B-2C are enlarged views of an example atrial septal wall.

FIG. 2D is a cross-sectional view taken along line 2D-2D of FIGS. 2B-2Cdepicting another example septal wall.

FIG. 3 is a block diagram depicting an exemplary embodiment of animplantable treatment device.

FIG. 4A is a perspective view depicting another exemplary embodiment ofan implantable treatment device.

FIG. 4B is a perspective view depicting an exemplary embodiment ofseveral coiled segments of an implantable treatment device.

FIG. 4C depicts a side view of the embodiment of the implantabletreatment device taken along direction 330 of FIG. 4A.

FIG. 4D is a schematic view depicting another exemplary embodiment ofthe implantable treatment device as viewed from direction 329 of FIG.4C.

FIG. 4E is cross-sectional view depicting the exemplary embodiment ofthe implantable treatment device depicted in FIG. 4A implanted within anexample heart.

FIGS. 4F-G are cross-sectional views of additional exemplary embodimentsof the treatment system with a delivery device.

FIGS. 5A-E are perspective views depicting additional exemplaryembodiments of the central portion the implantable treatment device.

FIGS. 6A-I are perspective views depicting additional exemplaryembodiments of either the first and/or the second end portions of theimplantable treatment device.

FIG. 7A-C, 8 and 9A-C are perspective views depicting additionalexemplary embodiments of the implantable treatment device.

FIG. 10A is a flow diagram depicting one exemplary method ofmanufacturing another exemplary embodiment of the implantable treatmentdevice.

FIG. 10B is a perspective view of an exemplary embodiment of a bodyshaping device.

FIGs. 11A-C are perspective views depicting additional exemplaryembodiments of an implantable treatment device.

FIG. 12 depicts another exemplary embodiment of the treatment systemwithin a heart.

FIG. 13 is a block diagram depicting an exemplary embodiment of adelivery device.

FIG. 14A is a perspective view depicting another exemplary embodiment ofthe treatment system.

FIG. 14B is a cross-sectional view depicting another exemplaryembodiment of the delivery device.

FIGS. 14C-F are perspective views depicting a portion of the septal walland an additional exemplary embodiment of the treatment system.

FIGS. 15A-D are perspective views depicting additional exemplaryembodiments of the delivery device.

FIGS. 16A-B are cross-sectional views depicting additional exemplaryembodiments of the treatment system.

FIG. 16C is a perspective view depicting the embodiment described withrespect to FIGS. 16A-B during delivery.

FIG. 17 is a cross-sectional view depicting an exemplary embodiment ofthe delivery device taken along line 17-17 of FIG. 14A.

FIG. 18A is a cross-sectional view of an exemplary embodiment of aneedle member.

FIGS. 18B-C are cross-sectional views depicting additional exemplaryembodiments of a delivery device.

FIGS. 19A-B are cross-sectional views depicting exemplary embodiments ofa delivery device and an implantable treatment device.

FIGS. 20A-B are schematic views depicting additional exemplaryembodiments of a delivery device and an implantable treatment device.

FIG. 21 is a cross-sectional view depicting another exemplary embodimentof a delivery device taken along lines 21-21 of FIG. 14A.

FIG. 22 is a block diagram depicting an exemplary embodiment of astabilization device.

FIGS. 23A-C are cross-sectional views depicting additional exemplaryembodiments of a stabilization device.

FIGS. 24A-B are perspective views depicting additional exemplaryembodiments of a stabilization device.

FIGS. 25A-D are cross-sectional views depicting additional exemplaryembodiments of a stabilization device.

FIGS. 26A-C are cross-sectional views depicting additional exemplaryembodiments of a stabilization device.

FIG. 27A is a perspective view depicting an additional exemplaryembodiment of a stabilization device.

FIG. 27B is a cross-sectional view depicting another exemplaryembodiment of a stabilization device.

FIGS. 28A-C are cross-sectional views depicting additional exemplaryembodiments of a centering device.

FIG. 28D is a schematic view depicting another exemplary embodiment of acentering device within a septal wall.

FIGS. 29A-C, 30 and 31 are schematic views depicting additionalexemplary embodiments of a centering device.

FIGS. 32A-B are cross-sectional views depicting additional exemplaryembodiments of a centering device.

FIG. 32C is a cross-sectional view depicting another exemplaryembodiment of a centering device with an exemplary embodiment of astabilization device.

FIG. 32D is a schematic view depicting another exemplary embodiment of acentering device with an exemplary embodiment of a stabilization device.

FIG. 33A is a longitudinal cross-sectional view of an exemplaryembodiment of a treatment system.

FIG. 33B is a radial cross-sectional view of another exemplaryembodiment of a treatment system taken along line 33B-33B of FIG. 33A.

FIG. 34A is a longitudinal cross-sectional view of an exemplaryembodiment of a treatment system.

FIG. 34B is a radial cross-sectional view of another exemplaryembodiment of a treatment system taken along line 34B-34B of FIG. 34A.

FIG. 34C is a longitudinal cross-sectional view of another exemplaryembodiment of a treatment system taken along line 34C-34C of FIG. 34A.

FIG. 35A is a longitudinal cross-sectional view of an exemplaryembodiment of a treatment system.

FIG. 35B is a radial cross-sectional view of another exemplaryembodiment of a treatment system taken along line 35B-35B of FIG. 35A.

FIG. 36A is a longitudinal cross-sectional view of an exemplaryembodiment of a treatment system.

FIG. 36B is a radial cross-sectional view of another exemplaryembodiment of a treatment system taken along line 36B-36B of FIG. 36A.

FIG. 37A is a longitudinal cross-sectional view of an exemplaryembodiment of a treatment system.

FIG. 37B is a radial cross-sectional view of an exemplary embodiment ofa treatment system taken along line 37B-37B of FIG. 37A.

FIGS. 38A-E are cross-sectional views of a septal wall depictingexemplary embodiments of the implantable treatment device.

FIGS. 39A-B are flow diagrams depicting an example of a method oftreating a septal defect.

FIG. 40 is a flow diagram depicting another exemplary method of treatinga septal defect.

DETAILED DESCRIPTION

Described herein are improved devices and methods for treating septaldefects. For ease of discussion, the devices and methods will bedescribed with reference to treatment of a PFO. However, it should beunderstood that the devices and methods can be used in treatment of anytype of septal defect including ASD's, VSD's and the like, as well asPDA's or other structural cardiac or vascular defects.

FIG. 1 is a block diagram depicting a distal portion of an exemplaryembodiment of a septal defect treatment system 100 configured to treat,and, preferably close, a PFO. In this embodiment, treatment system 100includes an elongate body member 101 configured for insertion into thevasculature of a patient (human or animal) having a septal defect. Bodymember 101 has a longitudinal axis 107, distal end 112 and can includeone or more lumens 102, each of which can be configured for achievingmultiple functions. Preferably, treatment system 100 includes animplantable device 103 (referred to herein as an “implant”) configuredto at least partially close a septal defect. Treatment system 100 caninclude a flexible elongate delivery device 104 configured to house anddeliver implant 103. To minimize the width of body member 101, implant103 can be deformable from the configuration desired after implantationto a configuration having a smaller cross-section for storage andhousing within delivery device 104 prior to implantation.

Treatment system 100 can also optionally include a stabilization device105 for stabilization of body member 101 during delivery of implant 103and a centering device 106 for facilitating the centering or theotherwise desired positioning of implant 103 for delivery. Althoughshown here as four separate components, any combination of body member101, delivery device 104, stabilization device 105 and centering device106 can be integrated together to reduce the number of components tothree, two or one total components in treatment system 100.

To better understand the many alternative embodiments of treatmentsystem 100, the anatomical structure of an example human heart having aPFO will be described in brief. FIG. 2A is an exterior/interior viewdepicting an example human heart 200 with a portion of the inferior venacava 202 and the superior vena cava 203 connected thereto. Outer tissuesurface 204 of heart 200 is shown along with the interior of rightatrium 205 via cutaway portion 201. Depicted within right atrium 205 isseptal wall 207, which is placed between right atrium 205 and the leftatrium located on the opposite side (not shown). Also depicted is fossaovalis 208, which is a region of septal wall 207 where the tissue isrelatively thinner than the surrounding tissue. PFO region 209 islocated near the upper portion beyond the fossa ovalis 208.

FIG. 2B is an enlarged view of septal wall 207 depicting PFO region 209in more detail as viewed from right atrium 205. PFO region 209 includesseptum secundum 210, which is a first flap-like portion of septal wall207. The edge of this flap above fossa ovalis 208 is referred to as thelimbus 211. FIG. 2C is also an enlarged perspective view of septal wall207, instead depicting septal wall 207 as viewed from left atrium 212.Here, PFO region 209 is seen to include septum primum 214, which is asecond flap-like portion of septal wall 207. Septum primum 214 andseptum secundum 210 partially overlap each other and define atunnel-like opening 215 between sidewalls 219 (indicated as dashed linesin FIGS. 2B-C) that can allow blood to shunt between right atrium 205and left atrium 212 and is commonly referred to as a PFO.

FIG. 2D is a cross-sectional view depicting an example PFO region 209taken along line 2D-2D of FIGS. 2B-C. Here, it can be seen that septumsecundum 210 is thicker than septum primum 214. Typically, the bloodpressure within left atrium 212 is higher than that within right atrium205 and tunnel 215 remains sealed. However, under some circumstances avalsalva condition can occur where the blood pressure within rightatrium 205 becomes higher than the blood pressure within left atrium 212and blood shunts from right atrium 205 to left atrium 212. Because mosttypical shunts occur in this manner and for purposes of facilitating thediscussion herein, region 217 in FIG. 2D will be referred to as PFOentrance 217, and region 218 will be referred to as PFO exit 218.

Many different variations of PFO's can occur. For instance, thickness220 of septum primum 214, thickness 221 of septum secundum 210, overlapdistance 222 and the flexibility and distensibility of both septumprimum 214 and septum secundum 210 can all vary. In FIGS. 2B-C, PFOentrance 217 and PFO exit 218 are depicted as being relatively the samesize with the width of tunnel 215, or the distance between sidewalls219, remaining relatively constant. However, in some cases PFO entrance217 can be larger than PFO exit 218, resulting in an tunnel 215 thatconverges as blood passes through. Conversely, PFO entrance 217 can besmaller than PFQ exit 218, resulting in an opening that diverges asblood passes through. Furthermore, multiple PFO exits 218 can bepresent, with one or more individual tunnels 215 therebetween. Also, inFIGS. 2B-D, both septum primum 214 and septum secundum 210 are depictedas relatively planar tissue flaps, but in some cases one or both ofseptum primum 214 and septum secundum 210 can have folded, non-planar,highly irregular shapes.

As will be described in more detail below, treatment of a PFO preferablyincludes inserting treatment system 100 into the vasculature of apatient and advancing body member 101 through the vasculature toinferior vena cava 202, from which access to right atrium 205 can beobtained. Once properly positioned within right atrium 205, deliverydevice 104 can be used to deliver implant 103 to PFO region 209,preferably by inserting implant 103 through septum secundum 210 andprimum 214 such that implant 103 lies transverse to tunnel 215 and canat least partially close tunnel 215.

FIG. 3 is a block diagram depicting one exemplary embodiment of implant103. Inplant 103 can be configured in an almost limitless number ofdifferent ways, as this block diagram shows. Here, implant 103 includesa first end portion 301, a second end portion 302 and a central portion303 preferably coupled therebetween. First and second end portions301-302 are each preferably configured to engage opposing surfaces ofseptal wall 207. First end portion 301 can be configured to engage thesurface of septal wall 207 on the right atrium (RA) side, while secondend portion can be configured to engage the surface of septal wall 207on the left atrium (LA) side. Although end portions 301-302 can beplaced anywhere within heart 200 as desired, in order to facilitate thedescription of implant 103 herein, first end portion 301 will bereferred to as RA portion 301 and second end portion will be referred toas LA portion 302.

Central portion 303 is preferably configured to fit within a manmade orsurgically created opening in either septum primum 214, septum secundum210 or both. Central portion 303 is also preferably configured to applya force adequate to bring end portions 301-302 towards one another whenimplanted, to be implantable into septal walls 207 of varying thicknessand to fit within elongate body member 101, the diameter of which ispreferably minimized for ease of insertion within the patient'svasculature.

Implant 103 can be configured in any manner desired to fit the needs ofthe application. Implant 103 can have any size and shape and can includeadditional portions not shown in FIG. 3 to achieve a different set offunctions. Implant 103 can also be fabricated in any desired manner andfrom any materials suitable for implantation within the patientincluding, but not limited to, elastic materials, superelasticmaterials, shape-memory materials, composite materials, polymericmaterials, coatings, drug containing materials, blends with radio-opaquematerials and biodegradable materials.

FIG. 4A is a perspective view depicting another exemplary embodiment ofimplant 103 shown in an “at rest” configuration. In this embodiment,implant 103 is configured in a coil-shaped manner with a wire-like body304 composed of an elastic material. Wire-like body 304 can have anywire-like cross-sectional shape including, but not limited to circular,elliptical, oval, rounded, arcuate, polygonal and any combinationthereof. Each portion 301-303 can be composed of one or more coiledsegments 306, with a coiled segment 306 being defined herein as asegment that is curved or otherwise shaped in any manner about one ormore axes. Thus, rounded, straight, irregular and polygonal segments areall considered to be coiled. A coiled segment 306 can be curved orotherwise shaped less than 360 degrees about the one or more axes. FIG.4B is a perspective view depicting an exemplary embodiment of severalcoiled segments 306, which could be used in any of portions 301-303. Inthis embodiment, each coiled segment 306 is coiled with a constant rateof curvature about the same axis 309. Coiled segments 306 haveapproximately the same width 310 and are stacked and separated by adistance 311, which will be referred to herein as stacking distance 311.

Referring back to FIG. 4A, implant 103 has an overall width 336. Centralportion 303 includes a plurality of coiled segments 306 havingsubstantially the same width 310. Each end portion 301-302 includes aplurality of coiled segments having varied widths or diameters 310. Inthis case, the width 310 of the outermost coiled segment 306 is thegreatest and the widths 310 of each successive coiled segment 306decreases as one approaches the innermost coiled segment 306. Each endportion 301-302 is coupled with central portion 303 via optionalgenerally straight sections 305. Generally straight sections 305 canprevent blood from shunting between the right and left atria throughopen interior region 327 of coiled central portion 303, by allowing theadjacent tissue to encroach upon and surround straight section 305.Plugs of bioabsorbable or hydrophilic material may also be provided tominimize such shunting. Generally straight sections 305 can also preventtissue from getting caught, or hung up, between central portion 303 andRA/LA portions 301/302. Each generally straight sections 305 is notrequired to be straight and, in fact, can have any non-coiled shape.Central portion 303 can be placed approximately equidistant from endportions 301-302, as depicted here, or central portion 303 can be placedcloser to one of end portions 301-302 than the other. Generally straightsections 305 are optional and can be included on only one side ofcentral portion 303 or omitted altogether, in which case the coiledsegments 306 of central portion 303 extend directly up to a coiledsegment 306 of each end portion 301-302.

The end tips 307 of body 304 are preferably atraumatic so as to minimizeinjury to cardiac tissue. In this embodiment, end tips 307 are roundedand have a larger diameter than body 304. End tips 307 can also beconfigured as floppy tips that are curled or coiled and can be flexibleor non-flexible. Also, it should be noted that any part of implant 103can be modified for imaging purposes. For instance, in this embodimentend tips 307 are radio-opaque to increase visibility of implant 103during imaging. Also, end tips 307 can be configured to facilitatedelivery. For instance, in one embodiment end tips 307 can be shaped tominimize the risk of becoming caught on any portion of the deliverydevice 104. In another embodiment, end tips 307 are configured tointerface with the delivery device 104 to allow manipulation of implant103 before, during or after delivery.

FIG. 4C depicts a side view of the embodiment of implant 303 taken alongdirection 330 of FIG. 4A. For ease of illustration, FIG. 4C depicts onlythe outermost coiled segment 306 of RA portion 301, transition section331 and the generally straight section 305 located between RA portion301 and central portion 303. Transition section 331 is an optionalsection of implant 103 that can be straight, curved or any other shape.FIG. 4D depicts RA portion 301, transition section 331 and the generallystraight section 305 located between RA portion 301 and central portion303 as viewed from direction 329 of FIG. 4C. Here, it can be seen thattransition section 331 connects to generally straight section 305 at 90degree angle 332. Angle 332 can be varied as desired, but values ofangle 332 approaching 0 degrees or 180 degrees are less preferable dueto the increased risk of RA portion 301 (or LA portion 302) being drawninto manmade opening 315, which is described in more detail below.

FIG. 4E is cross-sectional view depicting the exemplary embodiment ofimplant 103 depicted in FIG. 4A implanted within heart 200 using oneexemplary method of implantation. Here, an opening 315 has beensurgically created in septum primum 214 and septum secundum 210 andimplant 103 has been positioned such that central portion 303 resideswithin the opening 315. RA portion 301 and LA portion 302 are positionedon opposite sides of septal wall 207 to engage surface 320 of septumsecundum 210 and surface 321 of septum primum 214, respectively. Centralportion 303 preferably exerts a contractile force 312 to bring portions301-302 towards one another, which in turn preferably draws septumprimum 214 and septum secundum 210 together to at least partially closePFO tunnel 215. Typically, portions 301 and 302 will lie flat againstthe septa, but are illustrated as compressed conical coils for purposesof clarity. As mentioned above, the widths 310 of coiled segments 306 ofRA and LA portions 301-302 get progressively larger from the innermostto the outermost segment 306. If the rate of change of width 310 islarge enough to allow coiled segments 306 to pass through each other,then portions 301 and 302 can exert additional closure forces 313 and314, respectively, which oppose each other and assist central portion303 in closing PFO tunnel 215.

LA portion 302 and RA portion 301 can each be sized in any mannerdesired. Preferably, LA portion 302 is configured to have relativelylarger coiled segment widths 310, include relatively more coiledsegments 306 and exert a closure force over a relatively larger area 314than RA portion 301. This can be for one of at least two reasons. Aswill be described in more detail below, preferably, LA portion 302 isdeployed in PFO region 209 first and, once in contact with septal wall207, LA portion 302 is used to help deploy, or pull, portions 303 and301 from delivery device 104. Also, septum primum 214 is typicallythinner than septum secundum 210 and more likely to tear or deform tothe extent that LA portion 302 can be pulled though septum primum 214.

Preferably, implant 103 is configured to adjust to septal walls 207having varying degrees of thickness. Accordingly, central portion 303preferably has a compressibility sufficient to apply a closure force 312to thinner septal walls 207 while at the same time having anexpandability sufficient to accommodate thicker septal walls 207 withoutexcessive permanent deformation. In one exemplary embodiment, which isfor purposes of illustration only and should not be used to limit thescope of the invention in any way, central portion 303 is expandablefrom 3 to 8 millimeters (mm) without excessive permanent deformation.

As mentioned above, implant 103 can be deformable between aconfiguration suited for housing within delivery device 104 and theimplanted configuration depicted in FIG. 4E. FIG. 4F is across-sectional view of an exemplary embodiment of treatment system 100depicting delivery device 104 having an inner lumen 402 with implant 103housed therein. Implant 103 is preferably housed within lumen 402 untilbody member 101 is advanced within the patient into the desired positionwithin heart 200 for implantation, at which time implant 103 isdelivered to PFO region 209 through open distal end 403. Here, implant103 is deformed from the at rest, i.e., unbiased, configuration depictedin FIG. 4A into a generally straight configuration where coiled portions301-303 are mostly unwound into a relatively straight state. This housedconfiguration significantly reduces the overall anchor width 336 ofimplant 103 and allows the size of delivery device 104 and, in turn,body member 101 to be minimized.

FIG. 4G is a cross-sectional view of another exemplary embodiment oftreatment system 100 depicting delivery device 104 with implant 103 inthe housed configuration. Here, central portion 303 of implant 103remains coiled in a state similar to the resting state of FIG. 4A, whileRA/LA portions 301/302 are partially unwound into a relatively straightstate from the coiled rest state. Preferably, coiled segments 306 ofcentral portion 303 generally have smaller widths 310 than most of thecoiled segments 306 of RA/LA portions 301/302. Coiled segments 306having a smaller width, i.e., more tightly wound coils, can bepermanently deformed more easily when unwound and, therefore, bymaintaining central portion 303 in the coiled state, the risk ofpermanent deformation to central portion 303 is reduced. Implant 103 canbe deformed in any manner when housed within delivery device 104. Forcoil-like embodiments of implant 103, this can include deforming any orall of coiled segments 306, to any degree, in any portion 301-303.

To facilitate the deformation of implant 103 between the housedconfiguration and the implanted configuration depicted in FIG. 4E,implant 103 is preferably composed of an elastic material. Preferably,body 304 is composed of a titanium-nickel alloy such as NITINOL,although any elastic material can be used, including polymers,rubber-like materials, stainless steel, other metal alloys and the like.As one of skill in the art will recognize, the amount of closure force312-314, the degree of allowable deformation and the like will depend,in part, on the type of material used to form body 304.

FIGS. 5A-E are perspective views depicting additional exemplaryembodiments of central portion 303 of implant 103. Each of theseembodiments can be used with any RA portion 301 and LA portion 302. InFIG. 5A, central portion 303 includes a plurality of coiled segments 306where the stacking distance 311 between each segment 306 is relativelygreater than the embodiment of central portion 303 depicted in FIG. 5B.Generally, a smaller stacking distance 311 will provide a greaterclosure force 312, if all other implant parameters remain the same. Anystacking distance 311 can be used in central portion 303 as desired,including configurations where there is no gap between each coiledsegment 306, i.e., each coiled segment 306 lies flush with any adjacentcoiled segment 306. Use of a larger stacking distance 311 that providesfor gaps between adjacent coiled segments 306 allows the adjacent septaltissue to grow into the open interior region 327 of the coiled centralportion 303, which can provide positional stability to the device andreduce any risk of blood shunting through open region 327.

In FIG. 5C, central portion 303 includes a combination of coiledsections 324 and generally straight sections 305. It should be notedthat central portion 303 can include any number of one or more coiledsections 324 in any combination with any number of one or more generallystraight sections 305. As can be seen here, each coiled section 324 canbe configured differently from any other coiled section 324, i.e., eachcoiled portion can include a different number of coiled segments 306,with different stacking distances 311 and different widths 310, etc.

FIG. 5D depicts another exemplary embodiment where blocking material 326has been coupled with coil body 304. Blocking material 326 preferablyreduces any risk of blood shunting through the interior of coiledsegments 306, either by blocking blood flow directly or by facilitatingthe formation of blood clots within open interior region 327. In oneexemplary embodiment, blocking material 326 can include multiple DACRONfibers adhesively or mechanically coupled to the outer surface of body304. In another exemplary embodiment, a polymer or metal plug is placedin open interior region 327 to prevent blood flow. As one of skill inthe art will readily recognize, any type of plug, device, material orcoating can be used and attached to body 304 in any manner, the numerouscombinations of which will not be listed here.

Central portion 303 is not required to include a coiled section 324 andcan, in fact, be only a generally straight section 305. Furthermore,central portion 304 is not required to be formed from a wire-like body304 and can be configured in any manner desired as depicted in the blockdiagram of FIG. 3. For instance, central portion 303 can be formed froman elastomeric or rubber-like stretchable member, as depicted in FIG.5E.

Referring in more detail to RA portion 301 and LA portion 302, FIGS.6A-I are perspective views depicting multiple embodiments exemplary ofeither RA portion 301 or LA portion 302. Any of the RA/LA portions301/302 depicted here can be used with any embodiment of central portion303 described with respect to FIGS. 5A-E. For instance, an exemplaryembodiment of implant 103 can have RA portion 301 configured in a mannersimilar to that described with respect to FIG. 6A, central portion 303configured in a manner similar to that described with respect to FIG.5A, and LA portion 302 configured in a manner similar to that describedwith respect to FIG. 6B.

In FIG. 4A, RA/LA portions 301/302 include multiple stacked coiledsegments 306 having gradually decreasing widths 310 from the outermostto the innermost segment 306 (outermost being used to reference thesegments 306 on the far left and right of FIG. 4A). In FIG. 6A, RA/LAportions 301/302 include multiple coiled segments 306 having graduallyincreasing widths 310 from the outermost to the innermost segment 306.The embodiment of portions 301-302 described with respect to FIG. 4A canbe less susceptible to entering opening 315, due to the presence of arelatively larger coiled segment 306 coupled with transition region 305.

In both FIGS. 4A and 6A, coiled segments 306 of RA/LA portions 301/302are stacked in an inwards manner, i.e., the outermost segment 306 iscoupled with central portion 303 or generally straight section 305, ifpresent (as shown here) and RA/LA portion 301/302 overlaps centralportion 303. In FIGS. 6B-C, RA/LA portions 301/302 include multiplecoiled segments 306 stacked in an outwards manner, i.e., the innermostsegment 306 is coupled with central portion 303 or generally straightsection 305, if present (as shown here). Generally, stacking segments306 in an inwards manner will provide greater closure forces thanstacking in an outwards manner. In FIG. 6B, RA/LA portions 301/302include multiple coiled segments 306 having gradually increasing widths310 from the outermost to the innermost segment 306, while in FIG. 6C,RA/LA portions 301/302 include multiple coiled segments 306 havinggradually decreasing widths 310 from the outermost to the innermostsegment 306.

In FIG. 6D, RA/LA portions 301/302 are tightly stacked with a constantwidth 310 such that no gap exists between adjacent coiled segments 306.This embodiment of RA/LA portions 301/302 exhibits a high resistance tothe potential for being pulled into opening 315.

RA/LA portions 301/302 are not required to be implemented in a stackedconfiguration. For instance, in FIGS. 6E-F, RA/LA portions 301/302 eachinclude multiple coiled segments 306 having varying widths 310 arrangedin a generally co-planar fashion, i.e., for all segments 306 thestacking distance 311 is close to or equal to zero. In FIG. 6E, thesmallest coiled segment 306 is coupled with generally straight section305, while in FIG. 6F, the largest coiled segment 306 is coupled withgenerally straight section 305. To lessen the risk of RA/LA portions301/302 being pulled into opening 315 in the embodiment depicted in FIG.6F, transition section 331 is preferably positioned on the outside ofcoiled segments 306 such that, when implanted, coiled segments 306 arelocated between transition section 331 and septal wall 207.

In the embodiments discussed above, the radius of curvature of thecoiled segments 306, present in either RA/LA portions 301/302 or centralportion 303, is generally constant or varies at a constant rate,resulting in a circular, spiral or helical appearance when viewed fromthe side (e.g., direction 330 of FIG. 4A). It should be understood thatthe radius of curvature can vary at any rate, abruptly or gradual,allowing coiled segments 306 to take any shape or form desired, whetherin RA/LA portions 301/302 or central portion 303. For instance, FIGS.6G-H are schematic views depicting additional exemplary embodiments ofRA/LA portions 301/302 as viewed from the side. FIG. 6G depicts RA/LAportion 301/302 having an elliptical D shape. Here, RA/LA portion301/302 has an elliptical portion 334 and a generally straight portion335, which can be placed adjacent to fossa ovalis 208 to lessen theextent to which RA/LA portion 301/302 overlaps fossa ovalis 208 andminimize the risk of piercing or rupturing fossa ovalis 208. FIG. 6Gdepicts another exemplary embodiment of RA/LA portion 301/302 having agenerally pentagonal shape.

RA/LA portions 301/302 are not required to include coiled segments 306and are not required to be formed from a wire-like body 304. Asmentioned above, RA/LA portions 301/302 can be configured in any mannerdesired as depicted in the block diagram of FIG. 3. For instance, RA/LAportions 301/302 can be formed from an elastomeric or rubber-likemembrane 328 in an umbrella-like fashion, or a sheet-like fashion asdepicted in the exemplary embodiment of FIG. 61.

FIG. 7A-C are perspective views depicting additional exemplaryembodiments of implant 103 having a ribbon-like body 304. Ribbon-likebodies 304 can have a generally polygonal cross-section and can bedifferentiated from the wire-like bodies 304 depicted in FIGS. 4A-5E,which can have generally circular, rounded etc. cross-sections asdescribed above. FIG. 7A is an embodiment of implant 103 having aribbon-like body 304 configured similar to that of the embodimentdepicted in FIG. 4A. Generally, any of the embodiments described withrespect to wire-like bodies 304 can also be implemented with ribbon-likebodies 304. Ribbon-like bodies 304 can have any ribbon-likecross-sectional shape desired. FIGS. 7B-C are cross-sectional viewsdepicting ribbon-like body 304 having generally polygonal shapes. FIG.7B is a cross-sectional view depicting ribbon-like body 304 having agenerally tapered trapezoidal shape. FIG. 7C is a cross-sectional viewdepicting ribbon-like body 304 having a generally rectangular shape withrounded corners.

In addition to other parameters, the thickness of implant body 304 canvary as desired. For instance, FIG. 8 is a perspective view depictinganother exemplary embodiment of implant 103 having a wire-like body 304with varying thicknesses. Here, it can be seen that generally straightsection 305 is relatively thicker than the coiled segments 306 ofcentral portion 303, while interface 333 between generally straightsections 305 and transition sections 331 is relatively thicker still.Relatively thicker regions of body 304, whether formed from a wire,ribbon or other structure, generally have greater strength and lessflexibility than relatively thinner regions of body 304. Thus,relatively thicker regions can be used to add strength while relativelythinner regions can be used where added flexibility is desired.

Like the thickness, the surface of body 304 can also be varied asdesired. The surface can be modified directly or through etching,grinding, additional coatings or add-ons, which are applied to theunderlying body 304. The surface can be modified for any purposeincluding, but not limited to increasing surface friction with tissue,increasing the ability to engage tissue, allowing tissue in-growth,promoting healing, promoting scarring, promoting thrombogencity,preventing blood passage or shunting around or through implant 103,minimizing thrombus formation, promoting anti-coagulation (e.g., withdrugs such as heparin and the like), modifying imaging characteristics(e.g., radio-opacity and the like) and decreasing body surface friction(e.g., with a hydrophilic coating and the like).

FIGS. 9A-C are perspective views depicting just several additionalexemplary embodiments of implant 103 having a modified surface region340. The surface of implant 103 can be modified in any location and inany manner desired, including, but not limited to, etching, grinding,coating, drilling, and cutting. For instance, FIGS. 9A-C depict theinnermost coiled segment 306 of exemplary embodiments of RA/LA portion301/302. In FIG. 9A, wire-like body 304 has been etched or otherwisetreated such that modified surface region 340 is a textured surfaceincluding multiple recesses 341 for increasing surface friction andallowing coiled segment 306 to more easily grasp septal wall 207. Itshould be noted that any surface texture pattern can be used. In FIG.9B, a coating has been applied to ribbon-like body 304 to create anabrasive surface region 340, also to increase surface friction. In FIG.9C, apertures 342 in ribbon-like body 304 are present to facilitatetissue in-growth on and around modified surface region 340. Also, inthis embodiment the orientation of ribbon-like body 340 has been rotated90 degrees so that the widest surface is adjacent to the septal tissue.

As stated above, implant 103 can be configured in any manner desired inaccordance with the needs of the application. The following is anon-exhaustive list of just some exemplary factors one of skill in theart may consider in designing, configuring, manufacturing and/orotherwise implementing implant 103.

LA portion 302 can be configured to use compressive force 312 fromcenter portion 303 to hold septum primum 214 against septum secundum 210and at least partially close or seal PFO tunnel 215. LA portion 302 canalso be configured to maintain a stable position as central portion 303and RA portion 301 are deployed without being pulled through septumprimum 210. LA portion 302 can be configured to lie flush against septumprimum 214 when deployed and not to distort the native geometry oftunnel 215 to create residual shunts. LA portion 302 can be sized toprovide adequate coverage over PFO tunnel 215. (In one exemplaryembodiment, which is included as an example only and should not be usedto limit the invention, LA portion 302 has a maximum width 310 of 1.2 toaccommodate most large PFO tunnels 215.) LA portion 302, in combinationwith central portion 303 and RA portion 301, can be configured to exertenough closure force 314 to seal PFO tunnel 215 and prevent shuntingduring normal and valsalva atrial blood pressures. LA portion 302 canalso be configured: to be deployable with minimal and consistent pushforce (e.g., push force on pusher member 406, which will be described inmore detail below); so that the shape before and after deployment ispredictable; to be devoid of characteristics that cause chronic orexcessive tissue irritation, inflammation, etc.; and/or for visibilityduring imaging procedures.

Central portion 303 can be configured to maintain LA portion 302 and RAportion 301 in a state of contact with septal wall 207 with enoughclosure force 312 to at least partially close and seal PFO tunnel 215.Central portion 303 can also be configured: with an adequate springconstant (k) to prevent tunnel 215 from opening during normal andvalsalva atrial blood pressures; not to distort the native geometry oftunnel 215 and create residual shunts; to be deployable with minimal andconsistent push force (e.g., push force on pusher member 406, which willbe described in more detail below); for visibility during imagingprocedures; to expand or stretch to accommodate variable septal wallthicknesses without excessive permanent deformation; with adequatestrength to withstand any motion it may experience in vivo; to allow LAportion 302 or RA portion 301 to tilt, for instance, if the area ofdelivery is wedge shaped; so that central portion 303 does not pinch orsever any tissue that could embolize, for instance, with a springconstant low enough to prevent severing tissue; to exert adequateclosure force 312 to close any residual shunts that exist; and/or withmaximized width 310 and minimized strains to optimize fatigueperformance.

RA portion 301 can be configured to hold septum secundum 210 againstseptum primum 214 and at least partially close or seal PFO tunnel 215.RA portion 301 can also be configured: to lie flush against septumsecundum 210 when deployed and not to distort the native geometry oftunnel 215 to create residual shunts; to be deployable with minimal andconsistent push force (e.g., push force on pusher member 406, which willbe described in more detail below); so that the shape before and afterdeployment is predictable; to be devoid of characteristics that causechronic or excessive tissue irritation, inflammation, etc.; forvisibility during imaging procedures; and/or to resist being pulledthrough septal wall 207.

Also provided herein are methods of manufacturing implant 103. FIG. 10Ais a flow diagram depicting one exemplary method 350 of manufacturing anexemplary embodiment of a coil-like implant 103 having body 304, whichcan be wire, ribbon or the like, composed of NITINOL. First, at 351, asection of NITINOL, from which body 304 can be formed, is pre-processed.Pre-processing 351 can include adding a modified surface region 340having a desired texture, adjusting body thickness, adjusting thecross-sectional shape of body 304 and the like.

With a ribbon-like implant 103, pre-processing can include etching ofthe NITINOL section. Methods of etching NITINOL materials are readilyunderstood to one skilled in the art. For instance, a sheet of NITINOLis first etched or grinded or otherwise altered to vary thecross-sectional shape, thickness, surface texture and the like of one ormore sections present on the sheet. Etching of the NITINOL sheet canallow for the implementation of numerous different cross-sectionalshapes, thicknesses, surface textures and combinations thereof.Afterwards, each section of NITINOL can be cut from the sheet andtrimmed as desired.

At 352, the NITINOL section is fixed to body shaping device 380 inpreparation for heat treatment. Heat treatment of NITINOL can instillthe desired at rest configuration to body 304 and is well known to thoseof skill in the art. Accordingly, body shaping device 380 is preferablyshaped such that when the NITINOL section is coiled around body shapingdevice 380, it is in the final desired at rest configuration. Oneexemplary embodiment of body shaping device 380 is depicted in FIG. 10B.Here, body shaping device 380 is shaped for the exemplary embodiment ofimplant 103 depicted in FIG. 4A. Body shaping device 380 includes acentral body shaping portion 383 corresponding to the shape of centralportion 303, and two end body shaping portions 381 and 382 correspondingto the shape of RA portion 301 and LA portion 302, respectively. Endbody shaping portions 381 and 382 are preferably configured to telescopeover central body shaping portion 383 to allow for the inwards manner ofcoiling of RA/LA portions 301/302 over central portion 303. Centralportion 303 includes recesses 384 into which the NITINOL section can beplaced to form generally straight sections 305. End body shapingportions 381 and 382 also preferably include recess 385 that can allowfor each transition section 331.

Once wrapped around and fixed to body shaping device 380, at 353, theNITINOL section is then preferably heat treated to instill the desiredshape. Heat treating can occur at any time and temperature sufficient toinstill the desired at rest shape and level of elasticity in implant103. In one embodiment, which is included as an example only and shouldin no way be used to limit the invention, heat treating can occur at atemperature range of 500-550 degrees Celsius for approximately fiveminutes.

At 354, the NITINOL section is preferably cooled, e.g., by rapidquenching in room temperature water, then at 355, the NITINOL section ispreferably removed from body shaping device 380 and end tips 307 aretrimmed, if necessary, to the desired length to form body 304. Finally,at 356, any post-processing is performed, such as the addition ofradio-opaque markers, the shaping of end tips 307 and the addition ofany desired coatings or blocking material 326.

FIGs. 11A-C depict additional exemplary embodiments of implant 103.Specifically, FIG. 11A is a perspective view depicting an exemplaryembodiment of implant 103 formed from multiple bodies 304. Morespecifically, from central portion 303 to RA portion 301 and LA portion302, body 304 splits into separate wires which are then configured asshaped portions 390 and 391, which in this embodiment have substantiallypolygonal shapes. The shape and size of polygonal shaped portions 390and 391 can be configured as desired to facilitate PFO closure. Here,portions 390 and 391 are entirely connected such that implant 103 doesnot have discrete end tips 307. Polygonal shaped portions 390 and 391operate similar to coiled segments 306 and are deformable between ahoused configuration and an “at rest” deployed configuration as shownhere in FIG. 11A. FIG. 11B depicts RA portion 301 in the housedconfiguration. FIG. 11C depicts another exemplary embodiment whereportions 390 and 391 have “D” shapes. Each portion 390 and 391 is notentirely connected and each portion 390 and 391 has an atraumatic endtip 307. It should be noted that body 304 can split into any number ofseparate portions having any number of configurations. Also, althoughnot shown, implant 103 can include any number of separate bodies 304.

Turning now to the devices and methods for delivering implant 103, FIG.12 depicts another exemplary embodiment of treatment system 100 withinheart 200. Implant 103 is preferably delivered from right atrium 205,although delivery from left atrium 212 is also possible. Right atrium205 is preferably accessed via inferior vena cava 202. In thisembodiment, implant 103 is delivered from within delivery device 104. Tofacilitate delivery in this manner, longitudinal axis 108 of deliverydevice 104 is preferably substantially parallel, i.e., at least close toparallel but not necessarily parallel, to the normal axis 109 of thesurface of septal wall 207 into which implant 103 is to be delivered.However, as shown in FIG. 12, longitudinal axis 108 of delivery device104 is close to perpendicular to this normal axis 109 (shown hereextending into the page). To accommodate for this, treatment system 100is preferably configured for off-axis delivery, which allows theorientation of delivery device 104 to be changed so that thelongitudinal axis 108 of delivery device 104 is transverse to thelongitudinal axis 107 (not shown) of body member 101.

FIG. 13 is a block diagram depicting one exemplary embodiment ofdelivery device 104 configured for off-axis delivery. Here, deliverydevice 104 includes an off-axis (OA) delivery member 401. Deliverydevice 104 is preferably configured to grasp or engage cardiac tissue tosupport and/or facilitate orientation of delivery member 401.Accordingly, an optional tissue engagement device 404 is included withindelivery device 104. Delivery device 104 can also include a needlemember 405 for puncturing septal wall 207 and a pusher member 406 forpushing implant 103 from within delivery device 104.

FIG. 14A is a perspective view depicting another exemplary embodiment oftreatment system 100, including body member 101, delivery device 104 andstabilization device 105. Here, OA delivery member 401 is an elongateflexible tubular member having open distal end 410. Inner lumen 102 ofbody member 101 is preferably configured to slidably receive OA deliverymember 401, such that OA delivery member 401 can be advanced bothproximally and distally. Distal end 410 of OA delivery member 401 iscoupled with an elongate support structure 411 of body member 101 viaoptional grasping device 404. In this embodiment, grasping device 404includes an arm member 409 coupled with support structure 411 and OAdelivery member 401 with hinges 407 and 408, respectively. A biasingelement 413 can also be optionally included, to apply a bias force tomaintain arm member 409 in the position shown here. Stabilization device105 is also an elongate member preferably placed in a location to opposearm member 401.

FIG. 14B is a cross-sectional view depicting another exemplaryembodiment of OA delivery member 401 with embodiments of needle member405, pusher member 406 and implant 103 located within lumen 414. Needlemember 405 has an open distal end 415 and an inner lumen 414 in whichpusher member 406 and implant 103 are slidably received and housed. Inthis embodiment, implant 103 is deformed to the housed configurationwhere RA/LA portions 301/302 are relatively straightened but centralportion 303 remains in the coiled at rest configuration. As will bediscussed in more detail below, delivery of implant 103 is accomplishedby first orienting delivery device 104 in the desired orientationtransverse to longitudinal axis 107 such that distal end 410 is inproximity with septal wall 207, then advancing needle member 405 throughseptal wall 207 to create opening 315. After needle member 405 hasadvanced through septal wall 207 into left atrium 212, pusher member 406is advanced distally to push LA portion 302 of implant 103 from withinlumen 414. Once LA portion 302 is outside lumen 414, LA portion 302returns to the coiled at rest configuration. Needle member 405 can thenbe retracted proximally such that LA portion 302 engages septal wall 207and remains in left atrium 212. As needle member 405 is retractedthrough septal wall 207, central portion 303 deploys within opening 315.Once needle member 405 is retracted back into lumen 402, OA deliverymember 401 can be retracted from septal wall 207, for instance bypulling body member 101 proximally back, thereby allowing RA portion 301to deploy and engage septal wall 207 in a coiled configuration.

FIGS. 14C-F are perspective views depicting a portion of septal wall 207and an additional exemplary embodiment of treatment system 100 duringuse of delivery device 104 prior to insertion of needle member 405.Here, the preferred location for insertion of needle member 405 isindicated by location 419. FIG. 14C depicts treatment system 100 withdelivery device 401 in the on-axis position, where the longitudinal axes107-108 are generally or substantially parallel. Stabilization device105, the use and structure of which will be described in more detailbelow, is shown positioned within PFO tunnel 215. In FIG. 14D, OAdelivery member 401 has been retracted proximally with respect to bodymember 101 and in opposition to bias member 413, causing distal end 410to move away from stabilization device 105 by way of arm member 409 andhinges 407-408. In FIG. 14E, treatment system 100 is advanced distallyin direction 416 until the underside surface 417 of arm member 409 abutslimbus 211, at which point OA delivery member 401 can be advanceddistally with respect to body member 101 to force arm member 409 backtowards stabilization device 105 to clamp, or grasp limbus 211 betweenarm member 409 and stabilization device 105, which is preferably in asubstantially fixed position with respect to arm member 409. By graspinglimbus 211 in this manner, treatment system is effectively anchored toseptal wall 207.

In FIG. 14F, OA delivery member 401 is further advanced distally withrespect to body member 101, which causes OA delivery member to deflect,or arc outwards, in order to rotate distal end 410 about hinge 408 intothe desired orientation with respect to septal wall 207. Distal end 410is now preferably in contact with septal wall 207 at the desired needleinsertion location 419. As shown here, OA delivery member 401 is in anoutwardly arced state. The degree to which OA delivery member 401 arcsoutwards can be adjusted by altering the length of OA delivery member401 present outside of body member 101. Because needle member 405,pusher member 406 and implant 103 all preferably move within OA deliverymember 401, the radius of curvature of the arc is preferably kept largeenough to allow movement within OA delivery member 401. A very largeradius of curvature can result in sharp angles or kinking in OA deliverymember 401 that can make movement difficult.

As shown in FIG. 14F, longitudinal axis 108, as measured at distal end410, is now transverse to longitudinal axis 107. Preferably, thedelivery angle 418, which is the angle between longitudinal axis 107 andlongitudinal axis 108 as measured at distal end 410, is approximately 90degrees. Once distal end 410 is in the desired orientation, needlemember 405 can be advanced into septal wall 207.

The needle insertion location 419 can be placed in any desired location,but should be chosen based in part on the configuration and size ofimplant 103 and the degree of overlap between septum primum 214 andseptum secundum 210. For instance, in one exemplary embodiment, which isincluded for illustration only and in no way should be used to limit theinvention, needle insertion location 419 is placed between 3 and 7 mmfrom limbus 211. The position of needle insertion location 419 can bedetermined by the length of arm member 409, which in turn can positiondistal end 410 using limbus 211 as a point of reference. To allow foradded flexibility, the length of arm member 409 can be configured to beadjustable during the implantation procedure. Thus, arm member 409 ispreferably configured for at least two functions: (1) to stop travel ofbody member 101 at limbus 211 by abutting limbus 211 and (2) to positiondistal end 410 in the desired needle insertion location 419.

FIGS. 15A-D are perspective views depicting additional exemplaryembodiments of grasping device 404 in a pulled back position. In FIG.15A, arm member 409 is configured to engage limbus 211 with a contouredundersurface 417 that accommodates the shape of limbus 211 in order tofacilitate grasping or engagement. Undersurface 417 can also be texturedas desired to increase surface friction, or made lubricious to assist infriction-free centering, and, as shown here, undersurface can includeabutments 420 configured to fixably grasp limbus 211. Also, it should benoted that any type of hinges 407-408 can be used including, but notlimited to, the swivel type hinges depicted here.

FIGS. 15B-C depict exemplary embodiments of grasping device 404 wherehinges 407 and 408 are integrated into arm member 409. In FIG. 15B, armmember 409 includes two elastic wires 421 each configured to flex athinge positions 407 and 408, e.g., by reducing the thickness of thematerial at the hinge positions. Arm member 409 is preferably biasedtowards a downwards position, which can allow elimination of anyadditional biasing element 413. In FIG. 15C, arm member 409 isconfigured to be both flexible and stretchable and can be composed of anelastomeric or rubber-like material or thin or slotted metal orpolymeric material with the appropriate modulus. This flexibility andstretchability facilitates the conformance of arm member 409 to limbus211. Here, arm member 409 includes tubular portions 422 and 423 forcoupling arm member 409 with OA delivery member 401 and supportstructure 411, respectively.

FIG. 15D is a perspective view depicting yet another exemplaryembodiment of grasping device 404. Here, arm member 409 again includestwo flexible wires 420 and 421 that can be coupled with OA deliverymember 401. Like the embodiment described with respect to FIG. 15B,hinges 407 and 408 can be integrated into wires 420 and 421, which canbe biased towards a downwards position. As shown in FIG. 15D, wires 425and 426 are preferably routed through aperture 499 into a lumen 102within body member 101 and to the proximal end of body member 101, wherethey can be independently adjusted to control, or steer, OA deliverymember 401. For instance, distal movement of both wires 425 and 426moves distal end 410 of OA delivery member 401 in direction 495 andproximal movement of both wires 425 and 426 moves distal end 410 of OAdelivery member 401 in direction 496, as OA delivery member 401 permits.Distal advancement of wire 425 with respect to wire 426, alone or incombination with proximal movement of wire 426 with respect to wire 425,moves distal end 410 in lateral direction 497, while reverse movementmoves distal end 410 in lateral direction 498, as OA delivery member 401permits.

FIGS. 16A-B are cross-sectional views depicting additional exemplaryembodiments of treatment system 100 with delivery device 104. FIG. 16Adepicts a longitudinal cross-sectional view of treatment system 100 andFIG. 16B depicts a radial cross-sectional view of treatment system 100taken along line 16B-16B of FIG. 16A. Here, delivery device 104 includesa steerable OA delivery member 401, which is configured to be freelysteerable to position distal end 410 in the desired orientation atneedle insertion location 419. Accordingly, distal end 410 is preferablyleft unconnected with any grasping device 404 (not shown). Preferably,steerability is provided through the use of one or more pull wires 424coupled with distal end cap 475. In this embodiment, four pull wires470-473 are equally spaced apart from each other within lumen 402. Thisconfiguration allows for manipulation of distal end 410 to anythree-dimensional (X, Y, Z) orientation. For instance, pulling wire 470back proximally with respect to wires 471-473, or pulling wire 472 backproximally with respect to wires 470-471 and 473 allows movement ofdistal end 410 in the X-Z plane. Pulling wire 471 back proximally withrespect to wires 470 and 472-473, or pulling wire 473 back proximallywith respect to wires 470-472 allows movement of distal end 410 in theY-Z plane.

FIG. 16C is a perspective view depicting the embodiment described withrespect to FIGS. 16A-B during delivery. Here, distal end 410 has beenoriented in its needle insertion location 419 and longitudinal axis 108lies within both the X-Z and Y-Z planes. The degree of steerability canbe altered as desired for each individual application. For instance, theinclusion of additional pull back wires can provide for more finelycontrollable steerability, while the deletion of any of pull wires470-473 can eliminate freedom of steerability, but can simplify theoverall design of device 104. The design and use of steerable devices isalso discussed in parent U.S. patent application Ser. No. 10/847,747,filed on May 7, 2004.

As mentioned above, OA delivery member 401 is preferably configured toallow slidable movement of needle member 405, pusher member 406 andimplant 103 within inner lumen 402. Preferably, OA delivery member 401is configured so as to maintain a sufficient degree of structuralintegrity and kink resistance, while at the same time providing adequatetorque or twist control. In one exemplary embodiment, OA delivery member401 is composed of a flexible braided metal reinforced polymeric tubeconfigured to provide the desired amount of kink resistance and torquecontrol. In other exemplary embodiments, OA delivery member 401 can becomposed of a braided or unbraided polymeric tube. In yet anotherexemplary embodiment, OA delivery member 401 is composed of a metal tubehaving apertures located therein to provide added flexibility. Forinstance, OA delivery member 401 can be a NITINOL slotted tube, with thesize and spacing of each slot configured for optimal flexibility, kinkresistance and torque control. The apertures are preferably placed in alocation corresponding to the portion of OA delivery member 401 thatextends or arcs out, while the portion of OA delivery member 401proximal to this can be left solid without apertures to maintainresilience in OA delivery member 401 and provide resistance to push backfrom needle member 405 as it penetrates septal wall 207.

Furthermore, OA delivery member 401 can be coated to provide lowfriction surfaces to facilitate advancement of OA delivery member 401within body member 101 and the patient's body, as well as to facilitatemovement of needle member 405 within lumen 402. Pusher member 406 andneedle member 405 can be coated as well. For instance, FIG. 17 is across-sectional view depicting an exemplary embodiment of OA deliverymember 401 taken along line 17-17 of FIG. 14A. Here, pusher member 406includes an outer coating 480, needle member 405 includes both an innercoating 481 and an outer coating 482 and OA delivery member 401 includesboth an inner coating 483 and an outer coating 484. Coatings 480-484 canbe implemented for any purpose desired. For instance, in one embodiment,coatings 480-484 are composed of any material used to lower surfacefriction, including, but not limited to polymers such as polyethylene(PE), polytetrafluoroethylene, fluorinated ethylene/propylenecopolymers, silicones, hydrogels, hydrophilic coatings or polyurethane(PU) and the like. Preferably, a high density PE material is used thatis thin enough to provide the desired degree of flexibility while at thesame time providing a low friction surface.

Like OA delivery member 401, needle member 405 and pusher member 406 arealso preferably flexible elongate members. FIG. 18A is a cross-sectionalview of an exemplary embodiment of needle member 405. Distal end 415 ofneedle member 405 is preferably substantially sharp enough to penetratethe desired portion of septal wall 207. In this embodiment, distal end415 is tapered similar to a conventional needle. Also, needle member 405is preferably flexible enough to move within OA delivery member 401 whendeflected for off-axis delivery.

For instance, needle member 405 can include one or more openings, orapertures 436, to increase flexibility. Here, needle member 405 includesmultiple apertures 436 in various arrangements. Needle member 405 can befabricated from any desired material including, but not limited to,NITINOL and stainless steel, and apertures 436 can be formed in anymanner including, but not limited to, molding, milling, grinding, lasercutting, EDM, chemical etching, punching and drilling. The design anduse of flexible needles is also discussed in parent U.S. patentapplication Ser. No. 10/847,747, filed on May 7, 2004.

A first region 437 of needle member 405 includes apertures 436 locatedat various intervals around the circumference of needle member 405. Asecond region 438, located distal to the first region 437, includesapertures 436 on the lower portion of needle member 405. FIG. 18B is across-sectional view depicting an exemplary embodiment of needle member405 in a deflected state within an exemplary embodiment of OA deliverymember 401. Because apertures 436 in region 437 are located around thecircumference of needle member 405, region 437 is relatively moreflexible than region 438. In region 438, placement of apertures 436 onthe lower surface, reduces the possibility that implant 103 will catchor snag an aperture 436 during advancement of needle member 405 from OAdelivery member 401. In addition, distal tip 439 of needle member 405 isalso preferably aligned on the lower portion of needle member 405 toreduce the possibility that distal tip 439 will impact, catch, snag, ordamage OA delivery member 401.

Treatment system 100 can be configured to apply a suction-type force toany surface of septal wall 207 to allow needle member 405 to more easilypenetrate the septal tissue without excessive “tenting” of septal wall207 in response to the pressure applied by needle member 405. Forinstance, the proximal end of OA delivery member 401 can be coupled witha vacuum or pressure adjustment device configured to lower the air orfluid pressure within OA delivery member 401. The pressure is preferablylowered to a degree sufficient to create a suction-type force between OAdelivery member 401 and septal wall 207 thereby keeping septal wall 207in contact or in proximity with OA delivery member 401 while needlemember 405 is advanced into septal wall 207. Also, the suction-typeforce can be applied through needle member 405 instead of, or inaddition to OA delivery member 401.

Treatment system 100 preferably includes one or more sensors tofacilitate determination of when needle member 405 has entered leftatrium 212. For instance, in one exemplary embodiment, needle member 405includes a sensor at or near distal end 415. The sensor can be any typeof applicable sensor, such as a pressure sensor, thermal sensor, imagingdevice, acoustic device and the like. In one exemplary embodiment, apressure sensor is included that is configured to sense the bloodpressure change between right atrium 205 and left atrium 212. Thepressure sensor can be any type of pressure sensor including, but notlimited to, an electrical sensor and a fluid feedback sensor such as alumen within needle member 405 having an open distal end in fluidcommunication with the exterior environment. In an alternative exemplaryembodiment, distal end 415 of needle member 405 is configured to bevisible by an external or internal imaging device, which can then beused to track the position of distal end 415 with respect to septal wall207.

FIG. 18C is a cross-sectional view of another exemplary embodiment ofdelivery device 104. Here, distal end 440 of pusher member 406 isconfigured to push against central portion 303 of implant 103 as opposedto end tip 307 of RA portion 301. This reduces the likelihood that RAportion 301 will coil when pushed within lumen 414, which could resultin bunching of implant 103 within lumen 414 making delivery moredifficult. Because distal end 440 of pusher member 406 is located distalto RA portion 301, pusher member 406 includes a relatively thinnerportion 441 that can provide additional room for RA portion 301 withinlumen 414 as well as provide added flexibility to pusher member 406.Relatively thinner portion 441 is relatively thinner than distal end440, which is preferably thick enough to adequately engage centralportion 303. Distal end 440 can include a recess 442 to provide enoughroom for RA portion 301. Recess 442 can also be used to help positionimplant 103 during delivery. For instance, rotation of pusher member 406can cause implant 103 to rotate if implant 103 is still routed throughrecess 442. This can allow the proper rotational orientation of implant103 before or during delivery into septal wall 207. Distal end surface443 can be configured in any manner desired to facilitate proper contactand engagement of implant 103.

For instance, FIGS. 19A-B are cross-sectional views depicting exemplaryembodiments of pusher member 406 and implant 103. In FIG. 19A, distalend surface 443 is contoured with a rounded recessed portion 444 intowhich a coiled central portion 303 can rest and an elevated portion 445configured to fit within open interior region 327. As one of skill inthe art will readily recognize, the contours of distal end surface 443are dependent on the type and housed configuration of implant 103, aswell as the desired point of contact on implant 103. In FIG. 19B, distalend surface 443 is contoured with a narrow recessed portion 446 intowhich end tip 307 of RA portion 301 can rest.

Pusher member 406 can also be configured to releasably couple withimplant 103. For instance, in one exemplary embodiment, pusher member406 is tethered to implant 103 with a tether 485 in order to allowimplant 103 to be drawn back into needle member 405 if needed, such asin a case of improper deployment. If implant 103 is properly deployed,tether 485 can be released from pusher member 406. In another exemplaryembodiment, pusher member 406 can be configured to both push and pullimplant 103 while within needle member 405, as depicted in FIGS. 20A-B.

FIGS. 20A-B are schematic views depicting additional exemplaryembodiments of needle member 405, pusher member 406 and implant 103. InFIG. 20A, implant 103 is placed over outer surface 450 of needle member405 and end tips 307 of RA portion 301 and LA portion 302 can be routedthrough apertures 451 and 452, respectively, and housed within lumen414. To deliver implant 103, after needle member 405 has traversedseptal wall 207 into left atrium 212, pusher member 406 is used to pullimplant 103 back proximally to expose end tip 307 of LA portion 302 asdepicted in FIG. 20B. To grasp end tip 307, pusher member 406 caninclude any type of grasping device desired. Here, pusher member 406includes a clamp-type device 453. Once removed from aperture 452, LAportion 302 can enter the coiled state. As needle member 405 iswithdrawn back through septal wall 207, LA portion 302 engages septalwall 207 and cause implant 103 to slide off needle member 405. Pushermember 406 can also be used to push end tip 307 of RA portion 301 tofacilitate deployment. In this embodiment, proximally located end tip307 includes an aperture through which a tether 485 is routed for use asdescribed above.

Delivery device 104 can be configured to maintain the proper orientationof OA delivery member 401, needle member 405, pusher member 406 andimplant 103 during delivery. FIG. 21 is a cross-sectional view depictinganother exemplary embodiment of delivery device 104 taken along lines21-21 of FIG. 14A where delivery device 104 is configured to use a lockand key technique to maintain proper orientation. Here, the lock andkeys are implemented with a combination of abutments and correspondingrecesses. For instance, outer surface 450 of needle member 405 includesa recess 456 configured to receive an abutment 455 located on innersurface 457 of OA delivery member 401. Recess 456 can extendlongitudinally along needle member 405 for any desired distance toensure proper orientation even when needle member 405 is advanced andretracted within OA delivery member 401. Similarly, outer surface 458 ofpusher member 406 includes a recess 459 configured to receive anabutment 460 located on inner surface 461 of needle member 405. Likerecess 456, recess 459 can extend longitudinally along pusher member 406for any desired distance to ensure proper orientation when pusher member406 is advanced and retracted. As discussed above with respect to FIGS.18A-B, pusher member 406 can include recess 442 to accommodate for thepresence of RA portion 301. This recess 442 can also maintain implant103 in the proper orientation with respect to pusher member 406.

The distances that OA delivery member 401, needle member 405 and pushermember 406 are moved proximally and distally with respect to body member101, can be relatively small. Manual movement of these components, whilepossible, can be difficult. Treatment system 100 can include one or moreautomated systems or devices at the proximal end of body member 101 tofacilitate movement of these components and lessen the risk that eachcomponent is inadvertently advanced too far or not enough. The automatedsystems or devices can also be configured to apply the desired amount offorce to move each component and sense if too much force is being used,which could be indicative of an error in the delivery process.

To further facilitate movement of OA delivery member 401, needle member405 and pusher member 406, each can be optionally pre-shaped. Forinstance, in one exemplary embodiment, one or more of OA delivery member401, needle member 405 and pusher member 406 can include a curvedsection that corresponds to the desired deflected arc shape of OAdelivery member 401 depicted in FIG. 14F.

It should also be noted that needle member 405 can be excluded fromsystem 100 altogether. Pusher member 406 can deploy implant 103 througha pre-existing hole, or implant 103 can be configured with asubstantially sharp end tip 307 for creation of a hole while beingdeployed by pusher member 406.

As described with respect to FIG. 1, treatment system 100 can optionallyinclude stabilization device 105. FIG. 22 is a block diagram depictingan exemplary embodiment of stabilization device 105 within treatmentsystem 100. Here, stabilization device 105 is preferably configured tostabilize treatment system 100 during delivery of implant 103.Stabilization device 105 can have any configuration desired inaccordance with the needs of the application. For instance,stabilization device 105 can be configured as a body routed through PFOtunnel 215 or any portion of the patient's vasculature, such as superiorvena cava 203. Stabilization device 105 preferably includes an elongatestabilization member 501 and can optionally include grasping device 502,which is preferably configured to grasp nearby tissue in order tofacilitate stabilization.

FIGS. 23A-C are cross-sectional views depicting additional exemplaryembodiments of stabilization device 105 being used to in an exemplarymethod of stabilizing treatment system 100. Here, stabilization member105 is configured as an elongate member including an outer tubularsheath 501 having an inner lumen 504 configured to slidably receiveinner elongate pull member 505. Outer tubular sheath 501 and inner pullmember 505 are preferably semi-rigid, having enough rigidity tostabilize treatment system 100 while at the same time having enoughflexibility to allow movement and manipulation within the patient'svasculature and heart 200. In these embodiments, stabilization device105 is preferably configured to be routed from right atrium 205 throughPFO tunnel 215 into left atrium 212, where grasping device 502 can beused to cover a portion of septum primum 214 and anchor stabilizationdevice 105 thereto.

The nature of the tissue forming septum primum 214 can be irregular, forinstance including overlapping folds, variations in tissue thickness andvariations in distensibility, each of which can cause septum primum 214to move, or tent, when needle member 405 is advanced through. Theinclusion of grasping device 502 can also provide the additionaladvantage of holding septum primum 214 in place and reducing the risk oftenting.

Grasping device 502 preferably includes a flexible grasping element 506coupled with inner pull member 505. Here, grasping element 506 isconfigured as a rectangular element. Outer tubular sheath 501 preferablyincludes lumen 507 having open distal end 508, from which graspingelement 506 can be deployed. Lumen 507 can be configured with contouredsidewalls to facilitate deployment of grasping element 506. To deploygrasping element 506, inner member 505 can be pulled in a proximaldirection with respect to outer sheath 501, causing grasping element 506to advance through lumen 507 and out of distal end 508. Grasping element506 can optionally include an atraumatic end 512, which in thisembodiment is a radio-opaque element, which may be gold or platinum. Inthis embodiment, grasping element 506 is configured as a deformable,pre-shaped element having three main configurations.

FIG. 23A depicts grasping element 506 in a first configuration housedwithin lumen 507. This configuration is preferably used while treatmentsystem 100 is moved through the patient's vasculature and as well aswhen stabilization device 105 traverses PFO tunnel 215, as depictedhere. FIG. 23B depicts grasping element 506 in a second configurationpartially deployed from within lumen 507. Once stabilization device 105is advanced through PFO tunnel 215 and out of PFO exit 218, graspingelement 506 is preferably deployed to this configuration by pullinginner member 505 proximally with respect to outer sheath 501. In thisconfiguration, grasping element 506 can be used to catch the edge ofseptum primum 214 as stabilization device 105 is pulled slightly back inproximal direction 509. FIG. 23C depicts grasping element 506 in athird, fully deployed configuration, after inner member 505 has beenpulled back further. Grasping element 506 can optionally include arecess configured to engage an abutment on outer sheath 501 in thisconfiguration, which is preferably used to more fully grasp or engageseptum primum 214 to anchor stabilization device 105 thereto.

Once the delivery procedure is complete, inner member 505 can beadvanced distally with respect to outer sheath 501 to draw graspingelement 506 back within lumen 507. Any component of treatment system 100adequately coupled with stabilization device 105 is thereby alsoanchored to septum primum 214. One of skill in the art will readilyrecognize that this and similar embodiments of stabilization device 105can be used to engage any tissue flap or edge desired, not solely septumprimum 214.

Grasping device 502 can be configured in any manner desired inaccordance with the needs of the application. FIGS. 24A-B areperspective views depicting additional exemplary embodiments ofstabilization device 105 with grasping device 502. In FIG. 24A, graspingdevice 502 includes multiple grasping elements 506 for grasping over awider area. In FIG. 24B, grasping device 502 includes a wire-likegrasping element 506. Here, grasping element 506 is looped into lumen507 (not shown) via apertures 510 and 51 1, which communicate with lumen507.

FIGS. 25A-D are cross-sectional views depicting additional exemplaryembodiments of stabilization device 105. Here, grasping element 506 hasa flap-like shape with tapered inner surface 516 and is located ondistal end member 517 of outer sheath 501. Inner member 505 includes anabutment 514 on distal end portion 515 and is configured to push againstand apply a force to grasping element 506. FIG. 25A depicts graspingelement 506 in the first, housed configuration. To deploy graspingelement 506 to the second configuration for catching septum primum 214,inner member 505 is advanced distally with respect to outer sheath 501as depicted in FIG. 25B. Because of tapered inner surface 516, the moreinner member 505 is advanced distally, the more outwards deflection ofelement 506 will occur. To more fully grasp septum primum 214, innermember 505 (and body member 101, if necessary) is retracted proximallyby the desired amount, as depicted in FIG. 25C. Manufacture of thisembodiment can be made relatively simple. For instance, distal endmember 517 and grasping element 506 can be formed by laser or EDMcutting a NITINOL tube. In FIG. 25D, distal end member 517 is located ondistal end of inner member 505 and abutment 514 is located on sheath501.

FIGS. 26A-C are cross-sectional views of additional exemplaryembodiments of stabilization device 105. Here, outer sheath 501preferably includes an open distal end 518, from which grasping device502 can be deployed. Grasping element 506 is preferably located ondistal end portion 515 of inner member 505 and can be formed of adeformable elastic material such as stainless steel, NITINOL, shapememory polymers and the like. Grasping element 506 is preferablyconfigured to be slidable within inner lumen 504 and is preferablypre-shaped, such as by heat-treating NITINOL, so that grasping element506 can assume a desired shape when advanced from inner lumen 504. InFIG. 26A, grasping element 506 is depicted in the first, housedconfiguration within inner lumen 504. In FIG. 26B, inner member 505 hasbeen advanced distally to deploy grasping element 506 in the secondconfiguration for catching septum primum 214. In FIG. 26C, inner member505 has been advanced further distally to place grasping element 506 inthe third configuration for grasping septum primum 214. Embodiments ofstabilization device 105 where grasping device 502 can be deployed bypushing grasping device 502 out from within inner lumen 504, such asthat described with respect to FIGS. 26A-C, will be referred to hereinas “push out” embodiments.

FIG. 27A is a perspective view depicting an additional exemplaryembodiment of stabilization device 105 having a “push-out” graspingdevice 502. Here, grasping device 502 is shown in the fully deployedthird configuration having two grasping elements 506. It should be notedthat grasping device 502 can include any number of grasping elements506. Here, each grasping element 506 overlaps so as to provideadditional grasping force at location 419 where needle member 405insertion occurs. FIG. 27B is a cross-sectional view depicting anotherexemplary embodiment where grasping element 506 is configured to attractto a magnetic force 522 provided by magnet 523 coupled with inner member505. Once deployed, the magnetic force is preferably great enough topenetrate outer sheath 501 and septum primum 214 and attract elements506 to provide additional grasping force. Of course, magnet 523 can beplaced in any desired location, for instance, on outer sheath 501 atdistal end 518 or on grasping element 506, in which case inner member505 could be configured to attract to the magnetic force, or anycombination thereof.

It should be noted that, in order to provide additional surfacefriction, additional abutments can be included on grasping element 506and/or the surface of grasping element 506 can be etched or coated orotherwise textured.

As discussed with respect to FIG. 1, treatment system 100 can includecentering device 106 to facilitate proper placement of implant 103.Centering device 106 can be configured to align delivery device 104 inthe desired location with respect to the center of PFO tunnel 215.Although the term “centering” is used, it should be understood thatcentering device 106 can be configured to align delivery device 104 inany location, not necessarily the center of PFO tunnel 215.

FIGS. 28A-C are cross-sectional views depicting additional exemplaryembodiments of centering device 106. In this embodiment, centeringdevice 106 includes an elongate centering support member 601 having twoelongate flexible positioning members 602, referred to herein ascentering arms 602, located on opposite sides of and extending along thelength of support member 601. Support member 601 can include two lumens603, each configured to slidably receive a centering arm 602. Each lumen603 preferably has an open distal end 606 which opens to an open orrecessed portion 605 of support member 601. Each centering arm 602preferably extends through this recessed portion 605 and into seat 604preferably configured to receive distal end 607 of each centering arm602. Seat 604 is preferably located in recessed portion 605 in aposition opposite to lumen 603.

FIG. 28A depicts centering arms 602 at rest within recessed portion 605along the sides of support member 601. The length of recessed portion605 is indicated as length 609. FIG. 28B is a cross-sectional view ofcentering device 106 taken along line 28B-28B of FIG. 28A. As depictedhere, centering arms 602 are preferably configured as rectangular wirebands, although any configuration can be used as desired. Advancement ofcentering arms 602 in a distal direction causes distal end 607 tocontact seat 604 and forces centering arms 602 to extend outwards fromrecessed portion 605 as depicted in FIG. 28C. Configuration of centeringarms 602 as bands helps ensure that arms 602 extend directly away fromsupport member 601 in direction 611.

When centering device 106 is placed within PFO tunnel 215, centeringarms 602 can be extended until coming into contact with sidewalls 219,as depicted in FIG. 28D, which is a perspective view of centering device106 within PFO tunnel 215. Here, sidewalls 219 and PFO exit 218 areshown as dashed lines to indicate their presence underneath septumsecundum 210. When centering arms 602 are each advanced the same amountuntil contact with both sidewalls 219 is made, the extension distance608 of each arm 602 will likewise be the same amount and support member601 will be forced into a centered position within PFO tunnel 215.

In this manner, centering device 106 can be centered within PFO tunnel215 and can be used as a reference point for delivering implant 103.Preferably, centering device 106 is coupled with delivery device 104, sothat centering of centering device 106 will also cause centering ofdelivery device 104. Preferably, once implant 103 is delivered,centering arms 602 are retracted proximally into lumens 603 andcentering device can then be retracted through PFO tunnel 215. Surface610 of recessed portion 605 is preferably curved, or tapered, to reducethe risk that support member 601 will catch or become hung up on anytissue in or around PFO tunnel 215.

Here, the extended portions of centering arms 602 are shown as beinglocated entirely within PFO tunnel 215. One of skill in the art willreadily recognize that variation of length 609 of recessed portion 605will cause the extended portion of centering arms 602 to varyaccordingly.

Support member 601 and centering arm 602 can each be composed of anydesired material in accordance with the needs of the application.Preferably, support member 601 is composed of a flexible polymer, suchas polyimides, polyamides, polyproylene and the like. Preferably,centering arms 602 are composed of a flexible polymer or metal, such asNITINOL, stainless steel and the like.

In the embodiment described with respect to FIGS. 28A-D, centering arms602 have a curved or arcuate shape when extended from support member601. As the FIGS. 29A-C will show, centering arms 602 can be configuredto have any desired shape when extended. FIGS. 29A-B are schematic viewsdepicting additional exemplary embodiments of centering device 106 withcentering arms 602 extended in a three-sided and two-sided shapes,respectively. Preferably, portions 612 of centering arms 602 are madethinner than the surrounding portions, so that centering arms 602 have atendency to flex first in portions 612, allowing these polygonal shapesto be achieved.

Also, arms 602 can be pre-shaped to be biased to assume a desired shapewhen allowed to expand from recessed portion 605. For instance, in oneexemplary embodiment, arms 602 are composed of NITINOL and areheat-treated for pre-shaping. One of skill in the art will readilyrecognize, in light of this disclosure, that variation of the thicknessof arms 602 and pre-shaping can allow an almost limitless number ofshapes to be achieved, having curved portions, straight portions and anycombination thereof which can be symmetric or asymmetric.

As mentioned above, in some cases, sidewalls 219 of PFO tunnel 215 arenot equidistant along the length of PFO tunnel 215, causing PFO tunnel215 to diverge or converge from PFO entrance 217 to PFO exit 218.Divergence or convergence of PFO tunnel 215 can cause centering device106 to slip out from PFO tunnel 215 when arms 602 are extended. FIG. 29Cis a schematic view depicting another exemplary embodiment of centeringdevice 106 where each centering arm 602 is configured to extend with twooutcroppings 614. These outcroppings 614 can be placed outside PFOtunnel 215 to prevent centering device 106 from slipping out of PFOtunnel 215. Outcroppings 614 can be formed by making that portion ofcentering arm 602 relatively thicker than the surrounding portions,making outcropping 614 less likely to flex. A desired radius ofcurvature in centering arms 602 can be implemented by pre-shaping, or bygradually varying the thickness and/or width of centering arms 602,where a relatively thinner portion will correspond to a relativelylarger rate of curvature.

It should be noted that centering device 106 can include any number ofone or more arms 602 for centering/positioning purposes. FIG. 30 is aschematic view depicting another exemplary embodiment of centeringdevice 106 having one centering arm 602 extended within PFO tunnel 215.In this embodiment, PFO tunnel 215 is curved to one side and centeringarm 602 is positioned on the opposite side. Centering arm 602 can thenbe extended a predetermined distance to position centering device 106 inthe desired location.

In another exemplary embodiment, centering device 106 includes multiplearms 602 configured for use independently of each other to allow theuser to have increased control over the position of centering device 106within PFO tunnel 215. For instance, the user can adjust two opposingarms 602 to center device 106 between sidewalls 219 within tunnel 215,and then adjust a third arm 602 to position device 106 as desiredrelative to septum secundum 210 and septum primum 214. In another case,the user can use three or more arms 602 for centering based on thetunnel type or anatomy.

In some embodiments, it can be desirable to keep centering device 106within PFO tunnel 215 while needle member 405 is advanced through septalwall 207. To reduce the risk that needle member 405 will contactcentering device 106 during this procedure, support member 601 can beconfigured to deflect needle member 405. FIG. 31 is a schematic viewdepicting an exemplary embodiment of centering device 106 where supportmember 601 is a rigid cylindrical member 649 having a smooth, orpolished, surface 615 between lumen 603 and seat 604 (as shown in FIG.28A), which are formed in rigid extrusions 650 which are preferablemetal and located on member 649. Here, if sharpened distal end 415 ofneedle member 405 comes into contact with support member 601, it is morelikely to be deflected from rigid cylindrical member 649.

FIGS. 32A-B are cross-sectional views depicting additional exemplaryembodiments of centering device 106 where support member 601 includes anopen distal end 616 from which one or more pre-shaped centering arms 602can be extended. Centering arms 602 are preferably pre-shaped to theextended position allowing elimination of seat 604 and recessed portion605. Centering arms 602 are preferably deformable from a firstconfiguration to allow housing within inner lumen 617 of support member601 as depicted in FIG. 32A. In FIG. 32B, centering arms 602 are showndeployed from inner lumen 617 in their extended second configuration.Although in FIGS. 32A-B, centering arms 602 are shown as separateelements, the proximal end of the pre-shaped portion of each arm 602 canbe coupled together on a common elongate shaft.

It should be noted that the functionality of the various embodimentsdescribed herein can be combined and integrated together to reduce thenumber of components in treatment system 100, simplify the design oftreatment system 100 and so forth. For instance, FIG. 32C depicts anexemplary embodiment of treatment system 100 where the embodimentsdescribed with respect to FIGS. 27A and 32A-B have been integratedtogether to form device 110. Here, centering arms 602, similar to thatdepicted in FIGS. 32A-B each include grasping element 506 ofstabilization device 105, similar to that depicted in FIG. 27A, locateddistal to the centering portion 618. Here, centering device 106 is usedfor centering and stabilization, allowing the elimination of a separatestabilization device 105 from system 100.

For stabilization and centering, support member 601 is preferablyadvanced through PFO exit 218. Once in left atrium 212, centering arms602 can be advanced distally to deploy grasping elements 506 from thefirst, housed configuration, to the second and third configurations forcatching and grasping septum primum 214. Once septum primum 214 isgrasped, support member 601 can be retracted proximally with respect tocentering arms 602 in order to deploy centering portions 618 of each arm602. The centering portions 618 can then expand outwards and centerdevice 106, thereby preferably also centering body member 101 anddelivery device 104, while at the same time maintaining a grasp ofseptum primum 214.

FIG. 32D is a schematic view depicting another exemplary embodiment oftreatment system 100 where centering device 106 and stabilization device105 have been integrated together. Here, stabilization member 501includes two lumens 603 and seats 604 (not shown), and recessed portions605 for use with centering arms 602. After stabilization with device105, centering arms 602 can be extended in directions 611 to center orotherwise place combined device 110 in the desired position.

As discussed with respect to FIG. 1, delivery device 104, stabilizationdevice 105 and centering device 106 are each preferably used inconjunction with body member 101. Body member 101 can be configured inany manner desired in accordance with the needs of the application.FIGS. 33A-B are cross-sectional views depicting another exemplaryembodiment of treatment system 100 where body member 101 includes twolumens 630 and 631. FIG. 33A is a longitudinal cross-sectional view andFIG. 33B is a radial cross-sectional view taken along line 33B-33B ofFIG. 33A. Preferably, lumen 630 is configured to slidably receivedelivery device 104, while lumen 631 is configured to slidably receiveeither stabilization device 105 or an optional guidewire to facilitaterouting body member 101 through the patient's vasculature. The guidewirecan be placed in lumen 631 until body member 101 is in the desiredposition within the patient, at which time the guidewire can be removedand stabilization device 105 can be inserted. Also, centering device 106is preferably integrated with stabilization device 105, such as in theembodiment described with respect to FIG. 32D, in order to providetreatment system with both stabilization and centering capability. Inorder to prevent rotation of elongate body member 101 aroundstabilization device 105 during delivery, stabilization device ispreferably fixably coupled with either body member 101 or deliverydevice 104.

FIGS. 34A-C are cross-sectional views depicting another exemplaryembodiment of treatment system 100 where body member 101 includes fourlumens 630-633 as well as centering arms 602. Here, FIG. 34A is a firstlongitudinal cross-sectional view, FIG. 34B is a radial cross-sectionalview taken along line 34B-34B of FIG. 34A and FIG. 34C is a secondlongitudinal cross-sectional view taken along line 34C-34C of FIG. 34A.Preferably, lumen 630 is configured to slidably receive delivery device104, while lumen 631 is configured for any purpose, including receptionof stabilization device 105, a guidewire, dye infusion and the like.FIG. 34B depicts centering arms 602 within lumens 632-633 and FIG. 34Cdepicts centering arms 602 located within lumens 632-633, recessedportions 605 and seats 604. Here, recessed portions 605 and seats 604are located distal to grasping device 404 on elongate support section411. The distal portion of support section 411 can be placed within PFOtunnel 215 where centering arms 602 can be deflected for centering priorto deployment of implant 103 in left atrium.

FIGS. 35A-B are cross-sectional views depicting another exemplaryembodiment of treatment system 100 where body member 101 includes threelumens 630, 632 and 633 as well as centering arms 602. Here, FIG. 35A isa longitudinal cross-sectional view and FIG. 35B is a radialcross-sectional view taken along line 35B-35B of FIG. 35A. In thisembodiment, distal end 112 of body member 101 includes an atraumatic tip640, which in this embodiment is a floppy tip. Here, with the aid ofatraumatic tip 640, body member 101 is configured to be advanceablewithin the patient's vasculature without the aid of a guidewire.Accordingly, no additional lumen 631 is included for use with aguidewire. Also in this embodiment, stabilization device 105 has beenoptionally omitted, allowing body member 101 to achieve a relativelysmaller radial cross-section size. In another exemplary embodiment,atraumatic tip 640 is omitted and body member 101 is configured to beslidably advanced through a tubular guide catheter placed within thepatient's vasculature.

FIGS. 36A-B are cross-sectional views depicting another exemplaryembodiment of treatment system 100 where body member 101 includes fourlumens 630-633 as well as centering arms 602. Here, FIG. 36A is alongitudinal cross-sectional view and FIG. 36B is a radialcross-sectional view taken along line 36B-36B of FIG. 36A. Thisembodiment is similar to the embodiment described with respect to FIGS.34A-C except here, lumen 631 is configured for use with guidewire 641only, which can be the same size as or relatively thinner thanstabilization device 105, allowing the radial cross-section size oflumen 631 and body member 101 to be reduced.

FIGS. 37A-B are cross-sectional views depicting another exemplaryembodiment of treatment system 100 where body member 101 includes fourlumens 630-633 as well as centering arms 602. Here, FIG. 37A is alongitudinal cross-sectional view and FIG. 37B is a radialcross-sectional view taken along line 37B-37B of FIG. 37A. Thisembodiment is similar to the embodiment described with respect to FIGS.35A-C except here, lumen 631 is configured to facilitate exchange ofstabilization device 105 and guidewire 641. Proximal portion 642 oflumen 631 includes a divider 643 to separate lumen 631 into a firstportion 644 for stabilization device 105 and a second portion 645 forguidewire 641. Distal portion 646 of lumen 631 is preferably tapered tominimize the radial cross-section size of lumen 631. Exchange betweenstabilization device 105 and guidewire 641 is facilitated because bothcan reside within proximal portion 642 at the same time, with thedesired one of stabilization device 105 or guidewire 641 being advanceddistally through open distal end 647 for use.

It should be noted that in each of the embodiments described withrespect to FIGS. 33A-37B, functionality can be added or removed asdesired, while still remaining within the scope of treatment system 100.For instance, treatment system 100 can be further configured for dyeinfusion, pressure sensing, imaging, drug delivery, ablation, the use ofocclusive devices such as balloons and stents, facilitating theimplantation of coronary sinus pacing or defibrillation leads, the useof a stylet and the like. These and other additional types offunctionality can be added in any manner, including, but not limited tothe addition of one or more lumens 102, or the use of the existinglumens 102, integration directly into body member 101, or the additionof one or more extra body members 101.

In addition, treatment system 100 can include multiple delivery devices104 for delivery of multiple implants 103, multiple stabilizationdevices 105 for stabilization on multiple tissue surfaces, multiplecentering devices 106 and multiple body members 101 as desired. Iftreatment system 100 is used to access septal wall 207 via inferior venacava 202, the maximum radial cross-section size of body member 101 ispreferably 13 French or less, although it should be noted that any sizebody member 101 can be used in accordance with the needs of theapplication. Body member 101 can be constructed from any material asdesired, but is preferably constructed from a flexible polymer such aspolyethylene, polypropylene, nylon and the like.

Furthermore, it should be noted that any component or component portionwithin treatment system 100 can be configured to facilitate any type ofimaging, including, but not limited to, internal and external ultrasoundimaging, optical imaging, magnetic resonance imaging (MRI), andflouroscopy. For instance, radio-opaque portions can be used to increasethe visibility in flouroscopic applications while echolucent coatingscan be used to increase visibility in ultrasound applications. As anexample, in one exemplary embodiment OA delivery member 401 can beentirely radio-opaque, or can include portions that are radio-opaque,such as on distal tip 430 of FIG. 14A.

Also described herein are methods 700 and 800 of treating PFO tunnel215, preferably by at least partially closing PFO tunnel 215. Methods700 and 800 are preferably used with treatment system 100, but can beused with any medical system as desired. For ease of discussion, method700 will be described with respect to treatment system 100 and method800 will be described without reference to a particular treatmentsystem, although it should be understood that methods 700 and 800 can beused with or without treatment system 100. Generally, the steps ofmethods 700 will vary, in part, on the actual configuration of implant103, the number of implants 103 to be delivered, the location in whicheach implant 103 is to be delivered, the use of guidewire 641 or a guidecatheter and the optional use of stabilization device 105 and/orcentering device 106 or any combination thereof.

In FIG. 4E, implant 103 is delivered through both septum primum 214 andseptum secundum 210. It should be noted, however, that implant 103 canbe delivered in any location desired. FIGS. 38A-C are cross-sectionalviews of septal wall 207 depicting exemplary embodiments of implant 103in just several of the many alternate locations that can be used. InFIG. 38A, implant 103 has been delivered through the upper portion ofseptum secundum 210 adjacent to PFO exit 218. In FIG. 38B, implant 103has been delivered through the lower portion of septum primum 214,adjacent to PFO entrance 217 and near (or in) fossa ovalis 208. In FIG.38C, implant 103 has been delivered through septal wall 207 adjacent tosidewall 219, septum primum 214 and septum secundum 210.

Also, as many implants 103 can be used in any arrangement as desired.FIGS. 38D-E are views of septal wall 207 depicting exemplary embodimentsof multiple implants 103 in just several of the many alternatearrangements that can be used. In FIG. 38D, three implants 103 have beendelivered through both septum primum 214 and septum secundum 210. InFIG. 38E, six implants 103 have been delivered through septal wall 207adjacent to both sidewalls 219, septum primum 214 and septum secundum210.

Although there are many different implementations and variations ofmethod 700, for ease of discussion, method 700 will be described hereinas using one implant 103, delivered through both septum primum 214 andseptum secundum 210, using an exemplary embodiment of treatment system100 similar to that described above with respect to FIGS. 33A-B, wherebody member 101 is configured for use with stabilization device 105having centering device 106 integrated thereon.

FIGS. 39A-B are flow diagrams depicting an example of method 700. First,at 701, body member 101 is placed in proximity with PFO region 209. Asmentioned above, implant 103 can be delivered from left atrium 212 orright atrium 205. Preferably, implant 103 is placed into proximity withPFO region 209 by advancing body member 101 from the femoral vein toright atrium 205 in a conventional manner. For instance, in one example,a needle is inserted into the femoral vein and a guidewire is advancedthrough the needle into the femoral vein. The needle can then be removedand an access sheath can be routed over the guidewire, which can alsothen be removed. A J-tip guidewire, such as a 0.035“/0.038” guidewire,can be routed through the patient's vasculature into inferior vena cava202 and right atrium 205. From there, the guidewire can be routedthrough PFO tunnel 215 and into left atrium 212. Next, an exchangesheath or multi-purpose guide can then be advanced over the J-tipguidewire into left atrium 212, at which point the J-tip guidewire canbe removed. A relatively stiffer guidewire 641 can then be advancedthrough the exchange sheath or multi-purpose guide and into left atrium212 and optionally the pulmonary vein, which can act as an anchor forthe guidewire. Body member 101 can then be advanced over the guidewire641 into proximity with PFO region 209, preferably through PFO tunnel215 and into left atrium 212. In addition, a catheter or guidewirehaving a sizing device, such as a balloon, can be placed within PFOtunnel 215 to measure the size of PFO tunnel 215, for use in choosing aplacement location, implant size, etc.

At 702, guidewire 641, if present, can be removed. At 704, stabilizationdevice 105 is preferably advanced through lumen 631 and into left atrium212. At 706, body member 101 can be retracted proximally into rightatrium 205. Preferably, stabilization device 105 includes astabilization member 501 and grasping device 502 with grasping element506. At 708, grasping element 506 can be deployed from the first housedconfiguration to the second configuration for catching tissue, which, inthis example, is preferably septum primum 214.

Next, at 710, stabilization member 501 is preferably moved distallyuntil grasping element 506 catches septum primum 214. Then, at 712, OAdelivery member 401 can be retracted proximally with respect to bodymember 101 to raise arm member 409. At 714, body member 101 and OAdelivery member 401 are advanced distally until arm member 409 abutslimbus 211. At 716, centering device 106 can be used to center deliverydevice 104, preferably by deflecting centering arms 602. Once centered,if not already done so, at 717 stabilization device 105 can be fixablycoupled to delivery device 104 (e.g., with a rotating hemostasis valveor Tuohy-Borst valve and the like). Next, at 718, grasping element 506can be further deployed to the third configuration to grasp septumprimum 214 and lock stabilization device 105 to septum primum 214.Alternatively, either 716, 717, 718 or any combination thereof can beimplemented prior to 712. Also, 716-718 can be implemented in any orderdesired with respect to each other.

Once stabilized, centered and locked in place, OA delivery member 401 ispreferably advanced distally with respect to body member 101 to rotatedistal end 410 into the desired orientation with surface 320 of septumsecundum 210. At 722, needle member 405 can be advanced through septumsecundum 210 and septum primum 214 and into left atrium 212. Then, at724, pusher member 406 can be advanced distally to at least partiallydeploy LA portion 302 of implant 103 from distal end 415 of needlemember 405. In embodiments where centering arms 602 are in theirdeflected state for centering, it is possible for needle member 405 topass between centering arms 602 and stabilization member 501 wheninserted, based on needle insertion location 419. To avoid capture ofimplant 103 between centering arms 602 and stabilization member 501,centering arms 602 can be retracted proximally back into elongate body101 thereby removing them from seats 604 and preventing implant 103 frombeing trapped between centering arms 602 and stabilization member 501.Next, at 726, grasping element 506 can be moved to the secondconfiguration to free stabilization device 105 from septum primun 214.Alternatively, 726 can be performed before 724 if desired.

Then, at 728, LA portion 302 can be fully deployed if not already. At730, grasping element 506 can be removed to the first configuration,housed within stabilization member 501. Next, at 732, centering device106 can be moved to the undeployed configuration if not already,preferably by collapsing centering arms 602, after which stabilizationdevice 105 can be retracted proximally from PFO entrance 217 at 734. At736, needle member 405 can be withdrawn into OA delivery member 401 todeploy central portion 303 of implant 103 and at least a portion of RAportion 301. Here, at 738, an optional closure test can be performed toconfirm at least partial closure, and preferably substantially completeclosure, of PFO tunnel 215. Any desired closure test can be performedincluding, but not limited to, the introduction of gaseous bubblessimultaneously with imaging using contrast enhanced trans-cranialdoppler (CE-TCD), intracardiac echocardiography (ICE) and the like, orthe infusion of a radio-opaque dye imagable via flouroscopy. The testmay be performed by pulling back OA delivery member 401 as far asnecessary to deploy RA coil 301 and then test while device is at PFOentrance.

At 740, OA delivery member 401 can be retracted proximally with respectto body member 101 to complete deployment of RA portion 301, releaselimbus 211 and place OA delivery member 401 in the original position. Ifthe desired degree of closure is confirmed, then any tether connectionto implant 103 can be released at 742. Finally, at 744, body member 101can be retracted distally and withdrawn from the patient.

FIG. 40 depicts another exemplary method 800 of treating a septaldefect. At 802, limbus 211 is abutted with an abutment of a medicaldevice. Preferably, limbus 211 is engaged with the medical device andoptionally grasped such that the medical device is anchored to limbus211. Then, at 804, a hole in septal wall 207, preferably in septumsecundum 210, is created using limbus 211 as a point of reference. Forinstance, the hole can be created at a fixed or adjustable distance fromlimbus 211. At 806, the hole is used to facilitate delivery of a deviceconfigured to treat a septal defect. In one example, the device isdeployed through the hole such that it causes at least partial closureof the septal defect. In this example of method 800, limbus 211 isabutted and used as a reference. In another example of method 800, theedge of septum primum 214 is abutted and used as a reference. In otherexamples of method 800, one or both sidewalls 219 and/or fossa ovalis208 are abutted and used as points of reference.

It should be noted that any feature, function, method or component ofany embodiment described with respect to FIGS. 1-40 can be used incombination with any other embodiment, whether or not described herein.As one of skill in the art will readily recognize, treatment system 100and the methods for treating a septal defect can be configured oraltered in an almost limitless number of ways, the many combinations andvariations of which cannot be practically described herein.

The devices and methods herein may be used in any part of the body, inorder to treat a variety of disease states. Of particular interest areapplications within hollow organs including but not limited to the heartand blood vessels (arterial and venous), lungs and air passageways,digestive organs (esophagus, stomach, intestines, biliary tree, etc.).The devices and methods will also find use within the genitourinarytract in such areas as the bladder, urethra, ureters, and other areas.

Furthermore, the off-axis delivery systems may be used to pierce tissueand deliver medication, fillers, toxins, and the like in order to offerbenefit to a patient. For instance, the device could be used to deliverbulking agent such as collagen, pyrolytic carbon beads, and/or variouspolymers to the urethra to treat urinary incontinence and other urologicconditions or to the lower esophagus/upper stomach to treatgastroesophageal reflux disease. Alternatively, the devices could beused to deliver drug or other agent to a preferred location or preferreddepth within an organ. For example, various medications could beadministered into the superficial or deeper areas of the esophagus totreat Barrett's esophagus, or into the heart to promote angiogenesis ormyogenesis. Alternatively, the off-axis system can be useful in takingbiopsies, both within the lumen and deep to the lumen. For example, thesystem could be used to take bronchoscopic biopsy specimens of lymphnodes that are located outside of the bronchial tree or flexibleendoscopic biopsy specimens that are located outside thegastrointestinal tract. The above list is not meant to limit the scopeof the invention.

In some embodiments, the off-axis delivery system is used with ananchoring means in order to anchor the device to a location within thebody prior to rotation of the off-axis system. This anchoring means mayinvolve the use of a tissue grasper or forceps. It should be noted thatany device or set of devices can be advanced within the lumen of theoff-axis delivery system, including but not limited to needles, biopsyforceps, aspiration catheters, drug infusion devices, brushes, stents,balloon catheters, drainage catheters, and the like.

While the invention is susceptible to various modifications andalternative forms, a specific example thereof has been shown in thedrawings and is herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formdisclosed, but to the contrary, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritof the disclosure.

1. A treatment system, comprising: a first flexible elongate member; anda second flexible elongate member having a distal end adjustably coupledwith the first elongate member, wherein the orientation of the distalend is adjustable from a first orientation to a second orientation uponmovement of the second elongate member with respect to the firstelongate member.
 2. The treatment system of claim 1, wherein the distalend is rotatably coupled with the first elongate member.
 3. Thetreatment system of claim 1, wherein the distal end is flexibly coupledwith the first elongate member.
 4. The treatment system of claim 1,wherein the second elongate member is configured to deliver at least oneimplantable treatment device.
 5. The treatment system of claim 1,wherein the second elongate member has an inner lumen with an opendistal end configured to slidably receive a needle member.
 6. Thetreatment system of claim 5, wherein the needle member has an innerlumen with an open, substantially sharp, distal end.
 7. The treatmentsystem of claim 6, wherein the inner lumen of the needle member isconfigured to slidably receive an inner elongate member having a distalend configured to contact an implantable treatment device.
 8. Thetreatment system of claim 7, wherein the inner member is configured topush the implantable treatment device in a distal direction.
 9. Thetreatment system of claim 8, wherein the inner lumen of the needlemember is configured to house the implantable treatment device.
 10. Thetreatment system of claim 7, wherein the inner member is configured topull the implantable treatment device in a proximal direction.
 11. Thetreatment system of claim 10, wherein the needle member is configured tostore the implantable treatment device in a location at least partiallyexternal to the inner lumen of the needle member.
 12. The treatmentsystem of claim 7, wherein the distal end of the inner member has acontoured surface configured to contact the implantable treatmentdevice.
 13. The treatment system of claim 7, wherein a portion of theinner member proximal to the distal end of the inner member has asmaller width than a width of the distal end of the inner member. 14.The treatment system of claim 5, wherein the needle member comprises atleast one aperture configured to provide flexibility.
 15. The treatmentsystem of claim 5, wherein the needle member comprises a pressuresensor.
 16. The treatment system of claim 1, wherein the first elongatemember has a first longitudinal axis and the second elongate member hasa second longitudinal axis at the distal end of the second elongatemember, the first and second longitudinal axes being substantiallyparallel when the distal end of the second elongate member is in thefirst orientation and transverse when the distal end of the secondelongate member is in the second orientation.
 17. The treatment systemof claim 1, wherein the second elongate member is configured formovement with the vasculature of a patient when the distal end of thesecond elongate member is in the first orientation and for delivery ofan implantable treatment device to a septal wall of the patient when thedistal end of the second elongate member is in the second orientation.18. The treatment system of claim 17, wherein the distal end of thesecond elongate member is substantially normal to a surface of theseptal wall in the second orientation.
 19. The treatment system of claim1, wherein the distal end of the second elongate member is adjustablefrom the first orientation to the second orientation upon advancement ofthe second elongate member in a distal direction with respect to thefirst elongate member.
 20. The treatment system of claim 19, wherein aportion of the second elongate member is configured to extend outwardsfrom the first elongate member when the distal end of the secondelongate member is in the second orientation.
 21. The treatment systemof claim 20, wherein the first elongate member has an inner lumen withan open distal end configured to slidably receive the second elongatemember, the portion of the second elongate member configured to extendoutwards being located outside of the inner lumen of the first elongatemember.
 22. The treatment system of claim 1, wherein the second elongatemember comprises a braided sheath.
 23. The treatment system of claim 22,wherein the braided sheath is a polymeric braided sheath.
 24. Thetreatment system of claim 22, wherein the braided sheath is a metallicbraided sheath.
 25. The treatment system of claim 1, wherein the secondelongate member comprises a coating.
 26. The treatment system of claim1, wherein the first elongate member comprises a coating.
 27. Thetreatment system of claim 1, further comprising a tissue engagementdevice.
 28. The treatment system of claim 27, wherein the tissueengagement device comprises an arm member coupled between the firstelongate member and the distal end of the second elongate member. 29.The treatment system of claim 28, wherein the tissue engagement devicefurther comprises: a first hinge configured to rotatably couple the armmember with the first elongate member; and a second hinge configured torotatably couple the arm member with the distal end of the secondelongate member.
 30. The treatment system of claim 28, wherein the armmember is configured to pivot to engage tissue.
 31. The treatment systemof claim 30, wherein the arm member is configured to grasp tissue whenthe distal end of the second elongate member is in the secondorientation.
 32. The treatment system of claim 31, wherein the armmember is configured to clamp tissue between the arm member and one ofthe first elongate member or a third elongate member in a substantiallyfixed position with respect to the arm member.
 33. The treatment systemof claim 30, wherein the arm member has a surface configured to grasp alimbus of a septal wall of a patient.
 34. The treatment system of claim28, wherein the arm member is elastomeric.
 35. The treatment system ofclaim 28, wherein the arm member is superelastic.
 36. The treatmentsystem of claim 28, wherein the arm member is configured to steer thedistal end of the second elongate member.
 37. The treatment system ofclaim 36, wherein the arm member comprises two wires movable withrespect to each other and controllable by a user to steer the distal endof the second elongate member.
 38. The treatment system of claim 28,wherein the arm member is biased to a position adjacent to alongitudinal axis of the first elongate member.
 39. The treatment systemof claim 28, wherein the arm member is configured to position the distalend of the second elongate member in a desired location on a septal wallof a patient.
 40. The treatment system of claim 39, wherein the armmember has an adjustable length.
 41. The treatment system of claim 1,further comprising a third elongate member configured to stabilize theposition of at least one of the first elongate member and the secondelongate member.
 42. A treatment system for treating a septal defect,comprising: an implantable treatment device; a flexible elongatedelivery device having a first longitudinal axis and configured todeliver the implantable treatment device; and an elongate body memberhaving a second longitudinal axis and configured for insertion withinthe vasculature of a patient, the body member configured to slidablyreceive the delivery device, wherein the delivery device is configuredto deliver the implantable treatment device along the first longitudinalaxis when different than the second longitudinal axis.
 43. The treatmentsystem of claim 42, wherein the implantable treatment device is coiled.44. The treatment system of claim 42, further comprising a stabilizationdevice insertable within an opening in a septal wall and configured tostabilize the delivery device.
 45. The treatment system of claim 44,wherein the body member has an inner lumen configured to slidablyreceive the delivery device and stabilization device.
 46. The treatmentsystem of claim 44, wherein a positioning device is integrated with thestabilization device.
 47. The treatment system of claim 46, wherein thepositioning device is a flexible positioning member configured to extendoutwards from the stabilization device.
 48. The treatment system ofclaim 46, wherein the body member has a first inner lumen configured toslidably receive the delivery device and a second inner lumen configuredto slidable receive the stabilization device.
 49. The treatment systemof claim 46, wherein the stabilization device is configured to fixablycouple with the delivery device such that rotation of the deliverydevice about the stabilization device is prevented.
 50. The treatmentsystem of claim 44, wherein the stabilization device is configured tofixably couple with the delivery device such that rotation of thedelivery device about the stabilization device is prevented.
 51. Thetreatment system of claim 42, wherein the delivery device furthercomprises a grasping device coupled between the delivery device and thebody member.
 52. The treatment system of claim 42, further comprising apositioning device insertable within a patent foramen ovate tunnel. 53.The treatment system of claim 52, wherein the positioning device isintegrated with the body member.
 54. The treatment system of claim 53,wherein the positioning device is a flexible positioning member.
 55. Thetreatment system of claim 54, wherein the body member has an inner lumenconfigured to slidably receive the flexible positioning member, theinner lumen having a distal end configured to abut the distal end of theflexible positioning member and an open portion located proximal to thedistal end of the lumen, wherein the flexible positioning member isconfigured to extend from the open portion upon advancement of theflexible positioning member distally against the distal end of the innerlumen.
 56. The treatment system of claim 53, wherein the positioningdevice comprises a first and a second flexible positioning member andthe body member is insertable within a patent foramen ovale tunnel, thefirst and second flexible positioning members being configured toposition the body member within the tunnel.
 57. The treatment system ofclaim 56, wherein the first and second flexible positioning members areconfigured to center the body member within the tunnel.
 58. Thetreatment system of claim 53, wherein the body member has a first innerlumen configured to slidably receive the delivery device.
 59. Thetreatment system of claim 58, further comprising a stabilization deviceinsertable within an opening in a septal wall and configured tostabilize the delivery device, wherein the body member has a secondinner lumen configured to slidably receive the stabilization device. 60.The treatment system of claim 59, further comprising a guidewire,wherein the second inner lumen is configured to slidably receive theguidewire.
 61. The treatment system of claim 58, wherein the body memberhas a second inner lumen configured to slidably receive a guidewire. 62.The treatment system of claim 53, wherein the body member has a distalend with an atraumatic tip located thereon and the body member has aninner lumen configured to slidably receive the delivery device.